Drug approvals and EU decisions #

Every approval, licence and regulatory opinion for the large pharmaceutical companies we cover, over the last 5 years, on both sides of the Atlantic. Above the table is the part that has not happened yet: the medicines that have cleared Europe's scientific committee and are waiting on a decision from Brussels. Nothing here is medical advice, and nothing here is a recommendation to buy or sell a share. Spotted a wrong number? Tell us.

1647

decisions

155

new medicines

awaiting Brussels

173

this year

1183

at large pharma

Waiting on Brussels #

A medicine reaches the European market in two steps. The scientific committee adopts an opinion, then the European Commission decides. These 21 have cleared the first step and not the second, longest wait first. The gap is normally a couple of months.

Medicines with a positive European opinion awaiting a Commission decision
Opinion	Waiting	Medicine	Substance	Company	Designations
2025-05-22	476 days	Kinselby	resminostat	4Sc AG	orphan
2026-05-21	112 days	Colchicine Agepha Pharma	colchicine	Agepha Pharma s.r.o.
2026-06-23	79 days	Zokovea	ensitrelvir	Shionogi B.V.
2026-06-25	77 days	Xervyteg	Allogeneic faecal microbiota, pooled	MaaT PHARMA
2026-06-25	77 days	Denosumab Ascend	denosumab	Ascend GmbH	biosimilar
2026-06-25	77 days	Tacquell	Autologous melanoma-derived tumor infiltrating lymphocytes, ex vivo-expanded	Netherlands Cancer Institute
2026-06-25	77 days	Onswik	Insulin efsitora alfa	Eli Lilly
2026-06-25	77 days	Nylaspeg	pegfilgrastim	Qilu Pharma Spain S.L.	biosimilar
2026-07-23	49 days	Cavoley	pegfilgrastim	CuraTeQ Biologics s.r.o	biosimilar
2026-07-23	49 days	Riociguat Accord	riociguat	Accord Healthcare S.L.U.	generic
2026-07-23	49 days	Meplyffa	arimoclomol	Zevra Denmark A/S	orphan
2026-07-23	49 days	Icotyde	icotrokinra hydrochloride	J&J
2026-07-23	49 days	Tafamidis Accord	tafamidis	Accord Healthcare S.L.U.	generic
2026-07-23	49 days	Lyrokaul	lerodalcibep	LIB Therapeutics B.V.
2026-07-23	49 days	Nezglyal	leriglitazone	Minoryx Therapeutics S.L.	orphan
2026-07-23	49 days	Ruxolitinib Viatris	ruxolitinib hemifumarate	Viatris	generic
2026-07-23	49 days	Susvimo	ranibizumab	Roche
2026-07-23	49 days	Evlarco	obicetrapib;ezetimibe	A. Menarini International Licensing S.A.
2026-07-23	49 days	Ubeslo	obicetrapib	A. Menarini International Licensing S.A.
2026-07-23	49 days	Qezzaqar	catequentinib	CATS Consultants GmbH	orphan
2026-07-23	49 days	Lynavoy	Linerixibat	GSK	orphan

Filters #

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of 1647 decisions shown

The decisions #

Click any column header to sort. A new medicine is one approved for the first time; a new indication is an existing medicine cleared for a further use. US vaccines, cell therapies and gene therapies are licensed under a separate route and are marked as licences rather than approvals.

FDA approvals and EU regulatory decisions, newest first
Date	Decision	Medicine	Substance	Company	Designations
2026-08-28	FDA New medicine	Mimrylo	rusfertide	Takeda	priority review
2026-08-28	FDA New indication	Stelara	ustekinumab	J&J
2026-08-27	FDA New indication	Sunlenca	lenacapavir	Gilead
2026-08-27	FDA New indication	Sunlenca	lenacapavir	Gilead
2026-08-27	FDA New indication	Mounjaro, Mounjaro (Autoinjector)	tirzepatide	Eli Lilly
2026-08-27	FDA New indication	Mounjaro, Mounjaro (Autoinjector)	tirzepatide	Eli Lilly
2026-08-27	FDA Other approval			Gilead
2026-08-27	FDA Other approval	Bixlenvo	bictegravir and lenacapavir	Gilead	priority review
2026-08-26	FDA New indication	Zepbound, Zepbound (Autoinjector)	tirzepatide	Eli Lilly
2026-08-25	FDA New indication	Tivicay Pd	dolutegravir	GSK	priority review
2026-08-25	FDA New indication	Tivicay	dolutegravir	GSK	priority review
2026-08-25	FDA New indication	Ziihera	zanidatamab-hrii	Jazz	priority review
2026-08-24	FDA New indication	Imaavy	nipocalimab-aahu	J&J	priority review
2026-08-20	EU Authorisation	Aujemflu	Influenza vaccine	CSL
2026-08-19	FDA New medicine	Pasatru	garetosmab-grts	Regeneron	priority review
2026-08-13	FDA New medicine	Zenbexus	iberdomide	BMS	priority review
2026-08-05	FDA New medicine	Orzeyful	oveporexton	Takeda	priority review
2026-07-31	FDA New indication	Pluvicto	lutetium lu-177 vipivotide tetraxetan	Novartis
2026-07-28	FDA Other approval	Gwyn Lo	ethinyl estradiol + norelgestromin	Viatris
2026-07-24	FDA New medicine	Simtriyo	centanafadine	Otsuka	priority review
2026-07-24	FDA New indication	Xtandi	enzalutamide	Astellas
2026-07-24	FDA New indication	Xtandi	enzalutamide	Astellas
2026-07-23	EU Positive opinion	Icotyde	icotrokinra	J&J
2026-07-23	EU Positive opinion	Ruxolitinib Viatris	ruxolitinib	Viatris	generic
2026-07-23	EU Positive opinion	Susvimo	ranibizumab	Roche
2026-07-23	EU Positive opinion	Lynavoy	Linerixibat	GSK	orphan
2026-07-20	EU Authorisation	Etcamah	camizestrant	AstraZeneca
2026-07-16	FDA New indication	Fabhalta	iptacopan	Novartis	priority review
2026-07-15	FDA New medicine	Lipfendra	enlicitide	Merck	priority review
2026-07-15	EU Authorisation	Vijoice	alpelisib	Novartis	conditionalorphan
2026-07-15	EU Authorisation	Boey	trenibotulinumtoxinE	AbbVie
2026-07-15	EU Authorisation	Jascayd	nerandomilast	Boehringer Ingelheim
2026-07-14	FDA New indication	Retevmo	selpercatinib	Eli Lilly
2026-07-14	FDA New indication	Retevmo	selpercatinib	Eli Lilly
2026-07-13	FDA New indication	Verzenio	abemaciclib	Eli Lilly
2026-07-13	FDA New indication	Leqembi Iqlik	lecanemab-irmb	Eisai	priority review
2026-07-10	FDA New indication	Keytruda Qlex	berahyaluronidase alfa-pmph + pembrolizumab	Merck	priority review
2026-07-10	FDA New indication	Padcev	enfortumab vedotin-ejfv	Astellas	priority review
2026-07-10	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2026-07-09	FDA Other approval	Sarclisa Escena	isatuximab-irfc	Sanofi
2026-07-01	FDA New indication	Kisqali Femara Co-Pack (Copackaged)	letrozole + ribociclib	Novartis	priority review
2026-07-01	FDA New indication	Kisqali	ribociclib	Novartis	priority review
2026-06-30	EU Authorisation	Itvisma	onasemnogene abeparvovec	Novartis
2026-06-26	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2026-06-25	EU Positive opinion	Aujemflu	Influenza vaccine	CSL
2026-06-25	EU Positive opinion	Onswik	Insulin efsitora alfa	Eli Lilly
2026-06-24	FDA New indication	Ibrance	palbociclib	Pfizer
2026-06-24	FDA New indication	Ibrance	palbociclib	Pfizer
2026-06-24	FDA New indication	Keytruda Qlex	berahyaluronidase alfa-pmph + pembrolizumab	Merck
2026-06-24	FDA New indication	Keytruda	pembrolizumab	Merck
2026-06-19	EU Authorisation	Palbociclib Viatris	palbociclib	Viatris	generic
2026-06-19	EU Authorisation	Cenrifki	tolebrutinib	Sanofi
2026-06-18	FDA New indication	Zegalogue, Zegalogue (Autoinjector)	dasiglucagon	Zealand	priority review
2026-06-17	FDA New medicine	Utebzi	tebipenem pivoxil	GSK	priority review
2026-06-12	FDA New medicine	Ambelvist	gadoquatrane	Bayer
2026-06-12	FDA New indication	Truqap	capivasertib	AstraZeneca
2026-06-12	FDA New indication	Welireg	belzutifan	Merck	priority review
2026-06-12	FDA New indication	Keytruda Qlex	berahyaluronidase alfa-pmph + pembrolizumab	Merck	priority review
2026-06-12	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2026-06-12	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2026-06-11	FDA New indication	Alecensa	alectinib	Roche
2026-06-09	FDA New indication	Ebglyss	lebrikizumab-lbkz	Eli Lilly
2026-06-05	FDA New indication	Hympavzi	marstacimab-hncq	Pfizer	priority review
2026-05-29	EU Authorisation	Imdylltra	tarlatamab	Amgen	orphan
2026-05-28	FDA New indication	Imfinzi	durvalumab	AstraZeneca
2026-05-28	FDA New indication	Tremfya	guselkumab	J&J
2026-05-27	FDA New medicine	Decnupaz	pivekimab sunirine-pvzy	AbbVie	priority review
2026-05-23	FDA New indication	Uptravi	selexipag	J&J	priority review
2026-05-22	FDA New medicine	Hepcludex	bulevirtide-gmod	Gilead	priority review
2026-05-22	FDA New indication	Datroway	datopotamab deruxtecan-dlnk	Daiichi Sankyo	priority review
2026-05-21	EU Positive opinion	Vijoice	alpelisib	Novartis	conditionalorphan
2026-05-21	EU Positive opinion	Etcamah	camizestrant	AstraZeneca
2026-05-21	EU Positive opinion	Boey	trenibotulinumtoxinE	AbbVie
2026-05-21	EU Positive opinion	Jascayd	nerandomilast	Boehringer Ingelheim
2026-05-21	FDA New indication	Linzess	linaclotide	AbbVie	priority review
2026-05-20	FDA New indication	Venclexta	venetoclax	AbbVie
2026-05-18	FDA New indication	Zynyz	retifanlimab-dlwr	Incyte
2026-05-15	FDA New medicine	Baxfendy	baxdrostat	AstraZeneca	priority review
2026-05-15	FDA New indication	Tecentriq Hybreza	atezolizumab and hyaluronidase-tqjs	Roche	priority review
2026-05-15	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2026-05-15	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo
2026-05-15	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2026-05-14	FDA Other approval	Trimbow	beclomethasone dipropionate + formoterol +1 more	Chiesi
2026-05-13	FDA New indication	Fasenra	benralizumab	AstraZeneca
2026-05-08	FDA New indication	Vyvgart Hytrulo	efgartigimod alfa and hyaluronidase-qvfc	argenx	priority review
2026-05-08	FDA New indication	Vyvgart	efgartigimod alfa	argenx	priority review
2026-05-08	FDA New indication	Ocrevus	ocrelizumab	Roche	priority review
2026-05-01	FDA Other approval	Jakafi Xr	ruxolitinib	Incyte
2026-04-27	FDA New indication	Symbicort Aerosphere	budesonide + formoterol	AstraZeneca
2026-04-27	FDA New indication	Breztri Aerosphere	budesonide + formoterol +1 more	AstraZeneca
2026-04-27	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo
2026-04-24	FDA New indication	Keytruda Qlex	berahyaluronidase alfa-pmph + pembrolizumab	Merck
2026-04-24	FDA Other approval	Saphnelo	anifrolumab-fnia	AstraZeneca
2026-04-23	FDA Vaccine / cell therapy	Otarmeni	lunsotogene parvec-cwha	Regeneron
2026-04-23	EU Authorisation	Rhapsido	remibrutinib	Novartis
2026-04-23	EU Positive opinion	Palbociclib Viatris	palbociclib	Viatris	generic
2026-04-23	EU Positive opinion	Itvisma	onasemnogene abeparvovec	Novartis
2026-04-23	EU Positive opinion	Cenrifki	tolebrutinib	Sanofi
2026-04-23	FDA New indication	Perjeta	pertuzumab	Roche
2026-04-22	FDA New indication	Dupixent	dupilumab	Regeneron
2026-04-20	FDA New medicine	Idvynso	doravirine + islatravir	Merck
2026-04-20	EU Authorisation	mCombriax	influenza mRNA vaccine + COVID-19 mRNA vaccine	Moderna
2026-04-20	EU Authorisation	Ojemda	tovorafenib	Ipsen	conditionalorphan
2026-04-17	FDA New indication	Cosentyx	secukinumab	Novartis	priority review
2026-04-17	FDA New indication	Cosentyx	secukinumab	Novartis	priority review
2026-04-15	EU Authorisation	Enflonsia	clesrovimab	Merck
2026-04-15	FDA New indication	Itovebi	inavolisib	Roche
2026-04-15	FDA New indication	Wainua, Wainua (Autoinjector)	eplontersen	AstraZeneca
2026-04-15	FDA New indication	Stelara	ustekinumab	J&J
2026-04-09	FDA New indication	Vabysmo	faricimab-svoa	Roche
2026-04-02	FDA New indication	Eylea Hd	aflibercept	Regeneron
2026-04-01	FDA New medicine	Foundayo	orforglipron	Eli Lilly
2026-03-30	EU Authorisation	Supemtek	trivalent influenza vaccine	Sanofi
2026-03-30	FDA New indication	Zynyz	retifanlimab-dlwr	Incyte
2026-03-27	FDA New indication	Alyftrek	deutivacaftor + tezacaftor +1 more	Vertex	priority review
2026-03-27	FDA New indication	Trikafta (Copackaged)	elexacaftor, ivacaftor, tezacaftor + ivacaftor	Vertex	priority review
2026-03-27	FDA New indication	Trikafta (Copackaged)	elexacaftor, ivacaftor, tezacaftor + ivacaftor	Vertex	priority review
2026-03-27	FDA New indication	Spinraza	nusinersen	Biogen
2026-03-27	FDA New indication	Epkinly	epcoritamab-bysp	Genmab
2026-03-27	FDA Other approval	Ponlimsi	denosumab-adet	Teva
2026-03-26	FDA New medicine	Awiqli Flextouch	insulin icodec	Novo Nordisk
2026-03-26	EU Authorisation	Kayshild	semaglutide	Novo Nordisk	conditional
2026-03-26	EU Authorisation	Kygevvi	doxecitine + doxribtimine	UCB	exceptionalorphanprime
2026-03-26	EU Positive opinion	Imdylltra	tarlatamab	Amgen	orphan
2026-03-24	EU Authorisation	Rezurock	belumosudil	Sanofi	conditionalorphan
2026-03-20	FDA New indication	Opdivo	nivolumab	BMS	priority review
2026-03-19	FDA New indication	Wegovy, Wegovy Flextouch	semaglutide	Novo Nordisk
2026-03-17	FDA New medicine	Icotyde	icotrokinra	J&J	priority review
2026-03-12	FDA New indication	Cosentyx	secukinumab	Novartis
2026-03-09	FDA New indication	Wellcovorin	leucovorin	GSK	priority review
2026-03-06	FDA New indication	Xeljanz	tofacitinib	Pfizer
2026-03-06	FDA New indication	Xeljanz Xr	tofacitinib	Pfizer
2026-03-06	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2026-03-05	FDA New indication	Tecvayli	teclistamab-cqyv	J&J	priority review
2026-02-27	FDA New indication	Prezcobix	cobicistat + darunavir	J&J
2026-02-27	FDA New indication	Sogroya	somapacitan-beco	Novo Nordisk
2026-02-27	FDA New indication	Sogroya	somapacitan-beco	Novo Nordisk
2026-02-27	FDA New indication	Sogroya	somapacitan-beco	Novo Nordisk
2026-02-27	FDA New indication	Palynziq	pegvaliase-pqpz	BioMarin	priority review
2026-02-27	FDA Other approval	Prezcobix, Prezcobix Ped	cobicistat + darunavir and cobicistat +1 more	J&J
2026-02-26	EU Positive opinion	mCombriax	influenza mRNA vaccine + COVID-19 mRNA vaccine	Moderna
2026-02-26	EU Positive opinion	Rhapsido	remibrutinib	Novartis
2026-02-26	EU Positive opinion	Ojemda	tovorafenib	Ipsen	conditionalorphan
2026-02-26	FDA New indication	Hernexeos	zongertinib	Boehringer Ingelheim	priority review
2026-02-25	FDA New indication	Juxtapid	lomitapide	Chiesi	priority review
2026-02-23	FDA New indication	Dupixent	dupilumab	Regeneron	priority review
2026-02-19	FDA New indication	Calquence	acalabrutinib	AstraZeneca
2026-02-19	FDA New indication	Calquence	acalabrutinib	AstraZeneca
2026-02-19	FDA New indication	Venclexta	venetoclax	AbbVie
2026-02-13	FDA Other approval	Rybrevant Faspro	amivantamab and hyaluronidase-lpuj	J&J
2026-02-12	EU Authorisation	Exdensur	depemokimab	GSK
2026-02-12	EU Authorisation	mNexspike	COVID-19 mRNA vaccine	Moderna
2026-02-12	FDA New indication	Leqvio	inclisiran	Novartis	priority review
2026-02-12	FDA New indication	Leqvio	inclisiran	Novartis	priority review
2026-02-10	FDA New indication	Keytruda Qlex	berahyaluronidase alfa-pmph + pembrolizumab	Merck	priority review
2026-02-10	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2026-01-29	EU Positive opinion	Supemtek	trivalent influenza vaccine	Sanofi
2026-01-29	EU Positive opinion	Kayshild	semaglutide	Novo Nordisk	conditional
2026-01-29	EU Positive opinion	Rezurock	belumosudil	Sanofi	conditionalorphan
2026-01-29	EU Positive opinion	Kygevvi	doxecitine + doxribtimine	UCB	exceptionalorphanprime
2026-01-27	FDA New indication	Noxafil Powdermix Kit	posaconazole	Merck
2026-01-27	FDA New indication	Vyxeos	cytarabine + daunorubicin	Jazz	priority review
2026-01-27	FDA New indication	Noxafil	posaconazole	Merck
2026-01-27	FDA New indication	Noxafil	posaconazole	Merck
2026-01-27	FDA New indication	Noxafil	posaconazole	Merck
2026-01-27	FDA New indication	Darzalex Faspro	daratumumab and hyaluronidase-fihj	J&J
2026-01-21	FDA New indication	Verquvo	vericiguat	Merck
2026-01-19	EU Authorisation	Dawnzera	donidalorsen	Otsuka
2026-01-12	FDA New indication	Cerezyme	imiglucerase	Sanofi
2026-01-09	EU Authorisation	Inluriyo	imlunestrant	Eli Lilly
2026-01-08	EU Authorisation	Teduglutide Viatris	teduglutide	Viatris	generic
2026-01-08	EU Authorisation	Austedo	deutetrabenazine	Teva
2026-01-08	EU Authorisation	Teizeild	teplizumab	Sanofi	prime
2025-12-22	EU Authorisation	Wayrilz	rilzabrutinib	Sanofi	orphan
2025-12-22	FDA Other approval	Wegovy	semaglutide	Novo Nordisk
2025-12-19	FDA New indication	Mounjaro, Mounjaro (Autoinjector)	tirzepatide	Eli Lilly	priority review
2025-12-19	FDA New indication	Bylvay	odevixibat	Ipsen
2025-12-19	FDA New indication	Lunsumio, Lunsumio Velo	mosunetuzumab-axgb	Roche
2025-12-19	FDA Licence supplement	Riastap	Fibrinogen Concentrate	CSL
2025-12-19	FDA Other approval	Jascayd	nerandomilast	Boehringer Ingelheim	priority review
2025-12-18	FDA New indication	Vraylar	cariprazine	AbbVie	priority review
2025-12-18	FDA New indication	Vraylar	cariprazine	AbbVie	priority review
2025-12-18	FDA New indication	Vraylar	cariprazine	AbbVie	priority review
2025-12-18	FDA New indication	Vraylar	cariprazine	AbbVie
2025-12-17	FDA New indication	Zynyz	retifanlimab-dlwr	Incyte
2025-12-17	FDA Other approval	Rybrevant Faspro	amivantamab and hyaluronidase-lpuj	J&J	priority review
2025-12-16	FDA New medicine	Exdensur	depemokimab-ulaa	GSK
2025-12-16	FDA Vaccine / cell therapy	Fesilty	fibrinogen, humanchmt	Grifols
2025-12-15	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2025-12-12	FDA New indication	Akeega	abiraterone + niraparib	J&J	priority review
2025-12-11	EU Positive opinion	Exdensur	depemokimab	GSK
2025-12-11	EU Positive opinion	mNexspike	COVID-19 mRNA vaccine	Moderna
2025-12-11	FDA New indication	Blujepa	gepotidacin	GSK	priority review
2025-12-09	FDA New indication	Recarbrio	cilastatin + imipenem +1 more	Merck
2025-11-28	EU Authorisation	Imaavy	nipocalimab	J&J
2025-11-25	FDA New medicine	Voyxact	sibeprenlimab-szsi	Otsuka	priority review
2025-11-25	FDA New indication	Scemblix	asciminib	Novartis
2025-11-25	FDA New indication	Imfinzi	durvalumab	AstraZeneca	priority review
2025-11-24	FDA Vaccine / cell therapy	Itvisma	onasemnogene abeparvovec-brve	Novartis
2025-11-24	EU Authorisation	Kyinsu	insulin icodec + semaglutide	Novo Nordisk
2025-11-24	FDA New indication	Opdivo Qvantig	hyaluronidase-nvhy + nivolumab	BMS
2025-11-24	FDA New indication	Tecentriq Hybreza	atezolizumab and hyaluronidase-tqjs	Roche	priority review
2025-11-21	FDA New indication	Livtencity	maribavir	Takeda
2025-11-21	FDA New indication	Wegovy, Wegovy Flextouch	semaglutide	Novo Nordisk
2025-11-21	FDA New indication	Keytruda Qlex	berahyaluronidase alfa-pmph + pembrolizumab	Merck	priority review
2025-11-21	FDA New indication	Padcev	enfortumab vedotin-ejfv	Astellas	priority review
2025-11-21	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2025-11-20	FDA New indication	Retevmo	selpercatinib	Eli Lilly	priority review
2025-11-20	FDA New indication	Retevmo	selpercatinib	Eli Lilly	priority review
2025-11-19	FDA New medicine	Hyrnuo	sevabertinib	Bayer	priority review
2025-11-19	FDA New indication	Koselugo	selumetinib	AstraZeneca
2025-11-19	FDA New indication	Eylea Hd	aflibercept	Regeneron	priority review
2025-11-19	FDA New indication	Imdelltra	tarlatamab-dlle	Amgen	priority review
2025-11-19	FDA New indication	Darzalex Faspro	daratumumab and hyaluronidase-fihj	J&J
2025-11-18	FDA New indication	Epkinly	epcoritamab-bysp	Genmab	priority review
2025-11-17	EU Authorisation	Lynkuet	elinzanetant	Bayer
2025-11-17	EU Authorisation	Degevma	denosumab	Teva	biosimilar
2025-11-17	EU Authorisation	Ponlimsi	denosumab	Teva	biosimilar
2025-11-13	EU Positive opinion	Teduglutide Viatris	teduglutide	Viatris	generic
2025-11-13	EU Positive opinion	Dawnzera	donidalorsen	Otsuka
2025-11-13	EU Positive opinion	Inluriyo	imlunestrant	Eli Lilly
2025-11-13	EU Positive opinion	Teizeild	teplizumab	Sanofi	prime
2025-11-06	FDA New indication	Darzalex Faspro	daratumumab and hyaluronidase-fihj	J&J
2025-11-05	EU Positive opinion	Austedo	deutetrabenazine	Teva
2025-11-04	FDA New indication	Linzess	linaclotide	AbbVie	priority review
2025-11-03	FDA New medicine	Kygevvi	doxecitine + doxribtimine	UCB	priority review
2025-11-03	EU Positive opinion	Imaavy	nipocalimab	J&J
2025-10-29	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron	priority review
2025-10-27	FDA New indication	Opdivo Qvantig	hyaluronidase-nvhy + nivolumab	BMS
2025-10-27	FDA New indication	Opdivo Qvantig	hyaluronidase-nvhy + nivolumab	BMS
2025-10-24	FDA New medicine	Lynkuet	elinzanetant	Bayer
2025-10-24	FDA New indication	Winrevair	sotatercept-csrk	Merck	priority review
2025-10-23	FDA Other approval	Blenrep	belantamab mafodotin-blmf	GSK
2025-10-22	FDA New indication	Vyepti	eptinezumab-jjmr	Lundbeck
2025-10-20	FDA New indication	Beyfortus	nirsevimab-alip	AstraZeneca
2025-10-20	FDA Licence supplement	Gammaked, Gamunex-C	Immune Globulin Injection 10% Caprylate/Chromatography Purified	Grifols
2025-10-17	FDA New indication	Ozempic, Rybelsus	semaglutide	Novo Nordisk
2025-10-17	FDA New indication	Vyvgart Hytrulo	efgartigimod alfa and hyaluronidase-qvfc	argenx
2025-10-17	FDA New indication	Tezspire	tezepelumab-ekko	AstraZeneca
2025-10-17	FDA New indication	Vyvgart	efgartigimod alfa	argenx
2025-10-17	FDA New indication	Gazyva	obinutuzumab	Roche
2025-10-17	FDA New indication	Gazyva	obinutuzumab	Roche
2025-10-16	EU Positive opinion	Wayrilz	rilzabrutinib	Sanofi	orphan
2025-10-16	FDA New indication	Xeljanz	tofacitinib	Pfizer
2025-10-15	FDA Other approval			Merck	priority review
2025-10-10	FDA New indication	Uzedy	risperidone	Teva
2025-10-10	FDA New indication	Rinvoq	upadacitinib	AbbVie
2025-10-10	FDA New indication	Iclusig	ponatinib	Takeda
2025-10-09	FDA New indication	Praluent	alirocumab	Regeneron
2025-10-08	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron	priority review
2025-10-07	FDA New medicine	Jascayd	nerandomilast	Boehringer Ingelheim	priority review
2025-10-02	FDA New indication	Scemblix	asciminib	Novartis
2025-10-02	FDA New indication	Zepzelca	lurbinectedin	Jazz	priority review
2025-10-02	FDA New indication	Tecentriq Hybreza	atezolizumab and hyaluronidase-tqjs	Roche	priority review
2025-10-02	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2025-09-30	FDA New medicine	Rhapsido	remibrutinib	Novartis	priority review
2025-09-26	FDA New indication	Tremfya	guselkumab	J&J
2025-09-26	FDA New indication	Tremfya	guselkumab	J&J
2025-09-25	FDA New medicine	Inluriyo	imlunestrant	Eli Lilly
2025-09-25	FDA New indication	Evkeeza	evinacumab-dgnb	Regeneron	priority review
2025-09-24	EU Authorisation	Kisunla	donanemab	Eli Lilly
2025-09-24	EU Refusal	Elevidys	delandistrogene moxeparvovec	Roche	advanced_therapyorphan
2025-09-19	FDA New medicine	Keytruda Qlex	berahyaluronidase alfa-pmph + pembrolizumab	Merck	priority review
2025-09-19	FDA New indication	Tremfya	guselkumab	J&J
2025-09-19	FDA Other approval	Keytruda Qlex	berahyaluronidase alfa-pmph + pembrolizumab	Merck	priority review
2025-09-18	EU Positive opinion	Enflonsia	clesrovimab	Merck
2025-09-18	EU Positive opinion	Lynkuet	elinzanetant	Bayer
2025-09-18	EU Positive opinion	Kyinsu	insulin icodec + semaglutide	Novo Nordisk
2025-09-18	EU Positive opinion	Degevma	denosumab	Teva	biosimilar
2025-09-18	EU Positive opinion	Ponlimsi	denosumab	Teva	biosimilar
2025-09-18	FDA New indication	Opzelura	ruxolitinib	Incyte
2025-09-17	EU Authorisation	Voranigo	vorasidenib	Servier	orphan
2025-09-16	FDA New indication	Ibrance	palbociclib	Pfizer
2025-09-16	FDA New indication	Ibrance	palbociclib	Pfizer
2025-09-15	FDA New indication	Airsupra	albuterol + budesonide	AstraZeneca
2025-09-10	FDA New indication	Koselugo	selumetinib	AstraZeneca	priority review
2025-09-10	FDA New indication	Cabometyx	cabozantinib s-malate	Exelixis
2025-09-10	FDA Other approval	Koselugo	selumetinib	AstraZeneca	priority review
2025-09-09	FDA Other approval	Inlexzo	gemcitabine	J&J	priority review
2025-09-03	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2025-09-03	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2025-08-29	FDA New medicine	Wayrilz	rilzabrutinib	Sanofi
2025-08-29	FDA Other approval	Otezla, Otezla Xr	apremilast	Amgen
2025-08-29	FDA Other approval	Otezla, Otezla Xr	apremilast	Amgen
2025-08-29	FDA Other approval	Leqembi Iqlik	lecanemab-irmb	Eisai
2025-08-27	FDA Licence supplement	Comirnaty	COVID-19 Vaccine, mRNA	BioNTech
2025-08-25	EU Authorisation	Yeytuo	lenacapavir	Gilead
2025-08-22	EU Authorisation	Nintedanib Viatris	nintedanib	Viatris	generic
2025-08-19	EU Authorisation	Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris	emtricitabine + rilpivirine +1 more	Viatris	generic
2025-08-18	FDA New indication	Vyepti	eptinezumab-jjmr	Lundbeck
2025-08-15	FDA New indication	Wegovy, Wegovy Flextouch	semaglutide	Novo Nordisk	priority review
2025-08-14	EU Authorisation	Ogsiveo	nirogacestat	Merck KGaA	orphan
2025-08-14	FDA New indication	Lazcluze	lazertinib	J&J
2025-08-14	FDA New indication	Rybrevant	amivantamab-vmjw	J&J
2025-08-08	FDA New medicine	Hernexeos	zongertinib	Boehringer Ingelheim	priority review
2025-08-08	FDA New indication	Actemra	tocilizumab	Roche
2025-08-05	FDA New indication	Ajovy	fremanezumab-vfrm	Teva	priority review
2025-07-31	FDA New indication	Leqvio	inclisiran	Novartis
2025-07-31	FDA Other approval	Alhemo	concizumab	Novo Nordisk
2025-07-30	FDA New indication	Biktarvy	bictegravir + emtricitabine +1 more	Gilead
2025-07-28	EU Authorisation	Maapliv	amino acids	Recordati	exceptionalorphan
2025-07-28	FDA New indication	Sirturo	bedaquiline	J&J	priority review
2025-07-24	EU Positive opinion	Yeytuo	lenacapavir	Gilead
2025-07-24	EU Positive opinion	Zurzuvae	zuranolone	Biogen
2025-07-24	EU Positive opinion	Voranigo	vorasidenib	Servier	orphan
2025-07-24	EU Positive opinion	Kisunla	donanemab	Eli Lilly
2025-07-24	FDA New indication	Keytruda	pembrolizumab	Merck
2025-07-23	EU Authorisation	Blenrep	belantamab mafodotin	GSK
2025-07-23	FDA New indication	Otezla	apremilast	Amgen
2025-07-18	EU Authorisation	Emtricitabine / Tenofovir alafenamide Viatris	emtricitabine + tenofovir alafenamide	Viatris	generic
2025-07-18	EU Authorisation	Itovebi	inavolisib	Roche
2025-07-17	EU Authorisation	Ezmekly	mirdametinib	Merck KGaA	conditionalorphan
2025-07-16	FDA Licence supplement	Shingrix	Zoster Vaccine Recombinant, Adjuvanted	GSK
2025-07-11	FDA New indication	Kerendia	finerenone	Bayer	priority review
2025-07-10	FDA New indication	Motegrity	prucalopride	Takeda
2025-07-10	FDA New indication	Elrexfio	elranatamab	Pfizer
2025-07-03	FDA New indication	Isturisa	osilodrostat	Recordati
2025-07-01	FDA New indication	Kisunla	donanemab-azbt	Eli Lilly	priority review
2025-06-30	EU Authorisation	Alyftrek	deutivacaftor / tezacaftor / vanzacaftor	Vertex	orphan
2025-06-27	EU Authorisation	Ziihera	zanidatamab	Jazz	conditionalorphan
2025-06-23	FDA New medicine	Datroway	datopotamab deruxtecan-dlnk	Daiichi Sankyo	priority review
2025-06-20	FDA New indication	Descovy	emtricitabine + tenofovir alafenamide	Gilead
2025-06-20	FDA New indication	Descovy	emtricitabine + tenofovir alafenamide	Gilead
2025-06-20	FDA New indication	Tybost	cobicistat	Gilead
2025-06-20	FDA New indication	Tybost	cobicistat	Gilead
2025-06-20	FDA New indication	Benlysta	belimumab	GSK
2025-06-19	EU Authorisation	Tepezza	teprotumumab	Amgen
2025-06-19	EU Positive opinion	Emtricitabine / Rilpivirine / Tenofovir Alafenamide Viatris	emtricitabine + rilpivirine +1 more	Viatris	generic
2025-06-19	EU Positive opinion	Nintedanib Viatris	nintedanib	Viatris	generic
2025-06-19	EU Positive opinion	Ogsiveo	nirogacestat	Merck KGaA	orphan
2025-06-18	FDA New indication	Zejula	niraparib	GSK
2025-06-18	FDA New indication	Dupixent	dupilumab	Regeneron	priority review
2025-06-18	FDA Other approval	Yeztugo	lenacapavir	Gilead	priority review
2025-06-18	FDA Other approval	Yeztugo	lenacapavir	Gilead	priority review
2025-06-16	FDA New medicine	Andembry	garadacimab-gxii	CSL
2025-06-12	FDA New indication	Talzenna	talazoparib	Pfizer	priority review
2025-06-12	FDA New indication	Talzenna	talazoparib	Pfizer	priority review
2025-06-12	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2025-06-11	FDA New indication	Hectorol	doxercalciferol	Sanofi
2025-06-10	FDA New indication	Mavyret	glecaprevir + pibrentasvir	AbbVie	priority review
2025-06-10	FDA New indication	Mavyret	glecaprevir + pibrentasvir	AbbVie	priority review
2025-06-09	FDA New medicine	Enflonsia	clesrovimab-cfor	Merck	priority review
2025-06-06	FDA New indication	Vyloy	zolbetuximab-clzb	Astellas
2025-06-06	FDA New indication	Keytruda	pembrolizumab	Merck
2025-06-03	FDA New indication	Nubeqa	darolutamide	Bayer
2025-06-03	FDA New indication	Keytruda	pembrolizumab	Merck
2025-05-30	FDA New indication	Xofluza	baloxavir marboxil	Roche
2025-05-30	FDA New indication	Xofluza	baloxavir marboxil	Roche
2025-05-28	FDA New indication	Spevigo	spesolimab-sbzo	Boehringer Ingelheim
2025-05-23	FDA New indication	Opdivo	nivolumab	BMS	priority review
2025-05-23	FDA New indication	Yervoy	ipilimumab	BMS	priority review
2025-05-22	EU Positive opinion	Blenrep	belantamab mafodotin	GSK
2025-05-22	EU Positive opinion	Emtricitabine / Tenofovir alafenamide Viatris	emtricitabine + tenofovir alafenamide	Viatris	generic
2025-05-22	EU Positive opinion	Ezmekly	mirdametinib	Merck KGaA	conditionalorphan
2025-05-22	EU Positive opinion	Itovebi	inavolisib	Roche
2025-05-22	EU Positive opinion	Maapliv	amino acids	Recordati	exceptionalorphan
2025-05-22	FDA New indication	Kalydeco	ivacaftor	Vertex	priority review
2025-05-22	FDA New indication	Kalydeco	ivacaftor	Vertex	priority review
2025-05-22	FDA New indication	Kyprolis	carfilzomib	Amgen	priority review
2025-05-22	FDA New indication	Lupron Depot-Ped Kit	leuprolide	AbbVie
2025-05-22	FDA New indication	Nucala	mepolizumab	GSK
2025-05-22	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2025-05-22	FDA New indication	Prolia, Xgeva	denosumab	Amgen
2025-05-21	FDA New indication	Susvimo	ranibizumab	Roche
2025-05-20	FDA New indication	Cyltezo	adalimumab-adbm	Boehringer Ingelheim
2025-05-20	FDA New indication	Amjevita	adalimumab-atto	Amgen
2025-05-16	FDA Vaccine / cell therapy	Nuvaxovid	COVID-19 Vaccine, Adjuvanted	Sanofi
2025-05-15	FDA New indication	Zynyz	retifanlimab-dlwr	Incyte	priority review
2025-05-14	FDA New medicine	Emrelis	telisotuzumab vedotin-tllv	AbbVie	priority review
2025-05-14	FDA New indication	Welireg	belzutifan	Merck	priority review
2025-05-14	FDA New indication	Kadcyla	ado-trastuzumab emtansine	Roche
2025-05-09	FDA New indication	Rexulti	brexpiprazole	Otsuka
2025-05-02	EU Authorisation	Deqsiga	human normal immunoglobulin	Takeda
2025-04-29	FDA New medicine	Imaavy	nipocalimab-aahu	J&J	priority review
2025-04-28	FDA New indication	Rinvoq	upadacitinib	AbbVie
2025-04-25	EU Positive opinion	Tepezza	teprotumumab	Amgen
2025-04-25	EU Positive opinion	Alyftrek	deutivacaftor / tezacaftor / vanzacaftor	Vertex	orphan
2025-04-25	EU Positive opinion	Ziihera	zanidatamab	Jazz	conditionalorphan
2025-04-23	EU Authorisation	Lynozyfic	linvoseltamab	Regeneron	conditional
2025-04-23	FDA New indication	Ibrance	palbociclib	Pfizer
2025-04-23	FDA New indication	Ibrance	palbociclib	Pfizer
2025-04-21	FDA New indication	Keytruda	pembrolizumab	Merck
2025-04-17	FDA New indication	Eliquis	apixaban	BMS	priority review
2025-04-17	FDA New indication	Eliquis	apixaban	BMS	priority review
2025-04-17	FDA New indication	Dupixent	dupilumab	Regeneron
2025-04-15	EU Authorisation	Leqembi	lecanemab	Eisai
2025-04-15	FDA New indication	Welireg	belzutifan	Merck
2025-04-15	FDA New indication	Welireg	belzutifan	Merck
2025-04-15	FDA New indication	Isturisa	osilodrostat	Recordati
2025-04-11	FDA New indication	Opdivo	nivolumab	BMS
2025-04-11	FDA New indication	Yervoy	ipilimumab	BMS
2025-04-10	FDA New indication	Vyvgart Hytrulo	efgartigimod alfa and hyaluronidase-qvfc	argenx
2025-04-10	FDA New indication	Darzalex	daratumumab	J&J
2025-04-09	FDA New indication	Vitrakvi	larotrectinib	Bayer
2025-04-09	FDA New indication	Vitrakvi	larotrectinib	Bayer
2025-04-08	FDA New indication	Opdivo	nivolumab	BMS	priority review
2025-04-08	FDA New indication	Yervoy	ipilimumab	BMS	priority review
2025-04-07	FDA New indication	Amjevita	adalimumab-atto	Amgen
2025-04-07	FDA New indication	Cyramza	ramucirumab	Eli Lilly	priority review
2025-04-04	EU Authorisation	Datroway	datopotamab deruxtecan	Daiichi Sankyo
2025-04-02	FDA New medicine	Vanrafia	atrasentan	Novartis
2025-03-28	FDA New medicine	Qfitlia	fitusiran	Sanofi
2025-03-28	EU Authorisation	Tivdak	tisotumab vedotin	Genmab
2025-03-28	FDA New indication	Abilify Asimtufii	aripiprazole	Otsuka
2025-03-28	FDA New indication	Pluvicto	lutetium lu-177 vipivotide tetraxetan	Novartis
2025-03-28	FDA New indication	Abilify Maintena Kit	aripiprazole	Otsuka
2025-03-28	FDA New indication	Imfinzi	durvalumab	AstraZeneca	priority review
2025-03-27	FDA New indication	Rivfloza	nedosiran	Novo Nordisk
2025-03-26	FDA New indication	Cabometyx	cabozantinib s-malate	Exelixis
2025-03-25	FDA New medicine	Blujepa	gepotidacin	GSK	priority review
2025-03-24	EU Authorisation	Capvaxive	pneumococcal polysaccharide conjugate vaccine	Merck
2025-03-21	FDA New indication	Prezcobix	cobicistat + darunavir	J&J
2025-03-21	FDA Licence supplement	Jynneos	Smallpox and Mpox Vaccine, Live, Non-replicating	Bavarian Nordic
2025-03-20	FDA New indication	Fabhalta	iptacopan	Novartis	priority review
2025-03-20	FDA New indication	Amvuttra	vutrisiran	Alnylam	priority review
2025-03-20	FDA New indication	Tremfya	guselkumab	J&J	priority review
2025-03-19	FDA New indication	Keytruda	pembrolizumab	Merck
2025-03-13	FDA New indication	Sohonos	palovarotene	Ipsen
2025-03-07	FDA New indication	Tafinlar	dabrafenib	Novartis
2025-03-07	FDA New indication	Mekinist	trametinib + trametinib dimethyl sulfoxide	Novartis
2025-03-07	FDA New indication	Synjardy Xr	empagliflozin + metformin	Boehringer Ingelheim
2025-03-07	FDA New indication	Synjardy	empagliflozin + metformin	Boehringer Ingelheim
2025-03-07	FDA New indication	Mekinist	trametinib dimethyl sulfoxide	Novartis
2025-03-07	FDA New indication	Tafinlar	dabrafenib	Novartis
2025-03-06	EU Authorisation	Wainzua	eplontersen	AstraZeneca
2025-02-28	EU Authorisation	Vimkunya	Chikungunya vaccine	Bavarian Nordic	prime
2025-02-28	FDA New indication	Opsumit	macitentan	J&J	priority review
2025-02-28	FDA New indication	Imfinzi	durvalumab	AstraZeneca
2025-02-28	FDA New indication	Soliris	eculizumab	AstraZeneca	priority review
2025-02-28	FDA New indication	Tnkase	tenecteplase	Roche
2025-02-27	EU Positive opinion	Deqsiga	human normal immunoglobulin	Takeda
2025-02-27	EU Positive opinion	Lynozyfic	linvoseltamab	Regeneron	conditional
2025-02-27	FDA Licence supplement	Glassia	Alpha-1-Proteinase Inhibitor	Takeda
2025-02-21	FDA New indication	Xeljanz	tofacitinib	Pfizer
2025-02-21	FDA New indication	Xeljanz Xr	tofacitinib	Pfizer
2025-02-19	FDA New indication	Odefsey	emtricitabine + rilpivirine +1 more	Gilead
2025-02-19	FDA New indication	Odefsey	emtricitabine + rilpivirine +1 more	Gilead
2025-02-14	FDA Vaccine / cell therapy	Vimkunya	Chikungunya Vaccine, Recombinant	Bavarian Nordic
2025-02-14	FDA Vaccine / cell therapy	Penmenvy	Meningococcal Groups A, B, C, W and Y Vaccine	GSK
2025-02-14	FDA Other approval	Merilog, Merilog Solostar	insulin aspart-szjj	Sanofi
2025-02-12	EU Authorisation	Kostaive	zapomeran	CSL
2025-02-12	EU Authorisation	Welireg	belzutifan	Merck	conditional
2025-02-12	FDA New indication	Izervay	avacincaptad pegol	Astellas
2025-02-11	FDA Other approval	Evrysdi	risdiplam	Roche
2025-02-10	EU Authorisation	Beyonttra	acoramidis	Bayer
2025-02-10	EU Authorisation	Andembry	garadacimab	CSL
2025-02-07	FDA Other approval	Emblaveo	avibactam + aztreonam	AbbVie	priority review
2025-02-03	FDA New indication	Susvimo	ranibizumab	Roche
2025-01-31	FDA New indication	Paxlovid (Copackaged)	nirmatrelvir + ritonavir	Pfizer	priority review
2025-01-30	FDA New medicine	Journavx	suzetrigine	Vertex	priority review
2025-01-30	EU Positive opinion	Skojoy	aflibercept	Amgen	biosimilar
2025-01-30	EU Positive opinion	Datroway	datopotamab deruxtecan	Daiichi Sankyo
2025-01-30	EU Positive opinion	Pavblu	aflibercept	Amgen	biosimilar
2025-01-30	EU Positive opinion	Capvaxive	pneumococcal polysaccharide conjugate vaccine	Merck
2025-01-30	EU Positive opinion	Vimkunya	Chikungunya vaccine	Bavarian Nordic	prime
2025-01-30	EU Positive opinion	Tivdak	tisotumab vedotin	Genmab
2025-01-29	FDA New indication	Lenvima	lenvatinib	Eisai	priority review
2025-01-28	FDA New indication	Ozempic	semaglutide	Novo Nordisk
2025-01-28	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2025-01-28	FDA New indication	Yervoy	ipilimumab	BMS
2025-01-27	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2025-01-27	FDA New indication	Cyramza	ramucirumab	Eli Lilly
2025-01-24	FDA New indication	Leqembi	lecanemab-irmb	Eisai
2025-01-23	FDA New indication	Darzalex	daratumumab	J&J
2025-01-20	EU Authorisation	Kavigale	sipavibart	AstraZeneca
2025-01-20	EU Authorisation	Lazcluze	lazertinib	J&J
2025-01-17	FDA New medicine	Datroway	datopotamab deruxtecan-dlnk	Daiichi Sankyo
2025-01-17	FDA New indication	Spravato	esketamine	J&J	priority review
2025-01-16	FDA New indication	Calquence	acalabrutinib	AstraZeneca	priority review
2025-01-16	FDA New indication	Lumakras	sotorasib	Amgen	priority review
2025-01-16	FDA New indication	Calquence	acalabrutinib	AstraZeneca	priority review
2025-01-16	FDA New indication	Vectibix	panitumumab	Amgen	priority review
2025-01-15	FDA New indication	Omvoh	mirikizumab-mrkz	Eli Lilly
2025-01-15	FDA New indication	Omvoh	mirikizumab-mrkz	Eli Lilly
2025-01-13	EU Authorisation	Augtyro	repotrectinib	BMS	conditional
2024-12-27	FDA Other approval	Opdivo Qvantig	hyaluronidase-nvhy + nivolumab	BMS
2024-12-27	FDA Other approval	Opdivo Qvantig	hyaluronidase-nvhy + nivolumab	BMS
2024-12-26	FDA New indication	Wezlana	ustekinumab-auub	Amgen
2024-12-23	FDA New indication	Arixtra	fondaparinux	Viatris
2024-12-20	FDA New medicine	Alyftrek	deutivacaftor + tezacaftor +1 more	Vertex	priority review
2024-12-20	FDA New medicine	Alhemo	concizumab-mtci	Novo Nordisk	priority review
2024-12-20	FDA New indication	Zepbound, Zepbound (Autoinjector)	tirzepatide	Eli Lilly	priority review
2024-12-20	FDA New indication	Trikafta (Copackaged)	elexacaftor, ivacaftor, tezacaftor + ivacaftor	Vertex	priority review
2024-12-20	FDA New indication	Skyclarys	omaveloxolone	Biogen
2024-12-20	FDA New indication	Trikafta (Copackaged)	elexacaftor, ivacaftor, tezacaftor + ivacaftor	Vertex	priority review
2024-12-20	FDA New indication	Xigduo Xr	dapagliflozin + metformin	AstraZeneca
2024-12-19	FDA New indication	Xofluza	baloxavir marboxil	Roche
2024-12-19	FDA New indication	Xofluza	baloxavir marboxil	Roche
2024-12-18	FDA New indication	Invokamet Xr	canagliflozin + metformin	J&J	priority review
2024-12-18	FDA New indication	Invokamet	canagliflozin + metformin	J&J	priority review
2024-12-18	FDA New indication	Invokana	canagliflozin	J&J	priority review
2024-12-13	FDA New medicine	Crenessity	crinecerfont	Neurocrine Biosciences	priority review
2024-12-13	EU Authorisation	Alhemo	concizumab	Novo Nordisk
2024-12-13	FDA New indication	Orkambi	ivacaftor + lumacaftor	Vertex	priority review
2024-12-13	FDA New indication	Orkambi	ivacaftor + lumacaftor	Vertex	priority review
2024-12-13	FDA Other approval	Crenessity	crinecerfont	Neurocrine Biosciences	priority review
2024-12-12	EU Authorisation	Eltrombopag Viatris	eltrombopag	Viatris	generic
2024-12-12	EU Positive opinion	Beyonttra	acoramidis	Bayer
2024-12-12	EU Positive opinion	Kavigale	sipavibart	AstraZeneca
2024-12-12	EU Positive opinion	Kostaive	zapomeran	CSL
2024-12-12	EU Positive opinion	Andembry	garadacimab	CSL
2024-12-12	EU Positive opinion	Welireg	belzutifan	Merck	conditional
2024-12-12	EU Positive opinion	Lyvdelzi (previously Seladelpar Gilead)	seladelpar lysine	Gilead	conditionalorphanprime
2024-12-12	FDA New indication	Bridion	sugammadex	Merck	priority review
2024-12-11	FDA New indication	Keytruda	pembrolizumab	Merck
2024-12-09	FDA New indication	Ozempic, Rybelsus	semaglutide	Novo Nordisk
2024-12-04	FDA New indication	Imfinzi	durvalumab	AstraZeneca	priority review
2024-12-02	FDA Licence supplement	Jivi	Antihemophilic factor, PEGylated-aucl	Bayer
2024-11-27	FDA New indication	Wegovy, Wegovy Flextouch	semaglutide	Novo Nordisk
2024-11-25	FDA New indication	Sunlenca	lenacapavir	Gilead
2024-11-25	FDA New indication	Sunlenca	lenacapavir	Gilead
2024-11-22	FDA New indication	Pretomanid	pretomanid	Viatris
2024-11-22	FDA New indication	Tecvayli	teclistamab-cqyv	J&J
2024-11-22	FDA New indication	Lunsumio, Lunsumio Velo	mosunetuzumab-axgb	Roche
2024-11-22	FDA New indication	Phesgo	pertuzumab, trastuzumab, and hyaluronidase-zzxf	Roche
2024-11-20	FDA New medicine	Ziihera	zanidatamab-hrii	Jazz	priority review
2024-11-19	FDA New indication	Bimzelx	bimekizumab-bkzx	UCB
2024-11-18	EU Authorisation	Hympavzi	marstacimab	Pfizer
2024-11-15	EU Authorisation	Fluad	influenza vaccine	CSL
2024-11-15	EU Authorisation	Flucelvax	influenza vaccine	CSL
2024-11-14	EU Authorisation	Pomalidomide Teva	pomalidomide	Teva	generic
2024-11-14	EU Authorisation	Penbraya	meningococcal groups A, C, W, Y conjugate and group B vaccine	Pfizer
2024-11-14	EU Authorisation	Elahere	mirvetuximab soravtansine	AbbVie	orphan
2024-11-14	EU Positive opinion	Lazcluze	lazertinib	J&J
2024-11-14	EU Positive opinion	Augtyro	repotrectinib	BMS	conditional
2024-11-14	EU Positive opinion	Leqembi	lecanemab	Eisai
2024-11-13	FDA New indication	Verzenio	abemaciclib	Eli Lilly
2024-10-29	FDA New indication	Scemblix	asciminib	Novartis	priority review
2024-10-29	FDA New indication	Scemblix	asciminib	Novartis	priority review
2024-10-25	FDA New indication	Sarclisa	isatuximab-irfc	Sanofi
2024-10-25	FDA New indication	Sarclisa	isatuximab-irfc	Sanofi
2024-10-18	FDA New medicine	Vyloy	zolbetuximab-clzb	Astellas	priority review
2024-10-18	FDA New indication	Zepbound, Zepbound (Autoinjector)	tirzepatide	Eli Lilly
2024-10-18	FDA New indication	Botox, Botox Cosmetic	OnabotulinumtoxinA	AbbVie
2024-10-17	EU Positive opinion	Fluad	influenza vaccine	CSL
2024-10-17	EU Positive opinion	Flucelvax	influenza vaccine	CSL
2024-10-17	EU Positive opinion	Eltrombopag Viatris	eltrombopag	Viatris	generic
2024-10-17	EU Positive opinion	Wainzua	eplontersen	AstraZeneca
2024-10-17	EU Positive opinion	Alhemo	concizumab	Novo Nordisk
2024-10-16	FDA Other approval	Vyalev	foscarbidopa + foslevodopa	AbbVie
2024-10-15	FDA New indication	Fragmin	dalteparin	Pfizer
2024-10-11	FDA New medicine	Hympavzi	marstacimab-hncq	Pfizer
2024-10-11	FDA New indication	Kombiglyze Xr	metformin + saxagliptin	AstraZeneca
2024-10-11	FDA New indication	Onglyza	saxagliptin	AstraZeneca
2024-10-11	FDA New indication	Bimzelx	bimekizumab-bkzx	UCB
2024-10-11	FDA New indication	Bavencio	avelumab	Merck KGaA
2024-10-10	FDA New medicine	Itovebi	inavolisib	Roche	priority review
2024-10-03	FDA New indication	Opdivo	nivolumab	BMS
2024-09-27	EU Authorisation	Yuvanci	macitentan + tadalafil	J&J
2024-09-27	FDA New indication	Retevmo	selpercatinib	Eli Lilly
2024-09-27	FDA New indication	Retevmo	selpercatinib	Eli Lilly	priority review
2024-09-27	FDA New indication	Retevmo	selpercatinib	Eli Lilly	priority review
2024-09-27	FDA New indication	Retevmo	selpercatinib	Eli Lilly
2024-09-27	FDA New indication	Dupixent	dupilumab	Regeneron	priority review
2024-09-26	FDA New medicine	Cobenfy	trospium + xanomeline	BMS
2024-09-25	FDA New indication	Tagrisso	osimertinib	AstraZeneca	priority review
2024-09-20	FDA New indication	Apretude	cabotegravir	GSK
2024-09-20	FDA New indication	Cabenuva Kit	cabotegravir + rilpivirine	GSK	priority review
2024-09-20	FDA New indication	Vocabria	cabotegravir	GSK	priority review
2024-09-20	FDA New indication	Vocabria	cabotegravir	GSK
2024-09-20	FDA New indication	Bimzelx	bimekizumab-bkzx	UCB
2024-09-20	FDA New indication	Bimzelx	bimekizumab-bkzx	UCB
2024-09-20	FDA New indication	Bimzelx	bimekizumab-bkzx	UCB
2024-09-20	FDA New indication	Sarclisa	isatuximab-irfc	Sanofi	priority review
2024-09-20	FDA New indication	Actemra	tocilizumab	Roche
2024-09-20	FDA New indication	Actemra	tocilizumab	Roche
2024-09-19	EU Authorisation	Kayfanda	odevixibat	Ipsen	exceptional
2024-09-19	EU Authorisation	Iqirvo	elafibranor	Ipsen	conditionalorphan
2024-09-19	EU Authorisation	Vyloy	zolbetuximab	Astellas	orphan
2024-09-19	EU Positive opinion	Pomalidomide Teva	pomalidomide	Teva	generic
2024-09-19	EU Positive opinion	Hympavzi	marstacimab	Pfizer
2024-09-19	EU Positive opinion	Penbraya	meningococcal groups A, C, W, Y conjugate and group B vaccine	Pfizer
2024-09-19	EU Positive opinion	Elahere	mirvetuximab soravtansine	AbbVie	orphan
2024-09-19	FDA New indication	Rybrevant	amivantamab-vmjw	J&J
2024-09-17	FDA New indication	Evrysdi	risdiplam	Roche
2024-09-17	FDA New indication	Kisqali Femara Co-Pack (Copackaged)	letrozole + ribociclib	Novartis
2024-09-17	FDA New indication	Kisqali	ribociclib	Novartis	priority review
2024-09-17	FDA New indication	Fasenra	benralizumab	AstraZeneca
2024-09-17	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2024-09-13	FDA New medicine	Ebglyss	lebrikizumab-lbkz	Eli Lilly
2024-09-13	FDA New indication	Cimzia	certolizumab pegol	UCB
2024-09-13	FDA Other approval	Ocrevus Zunovo	ocrelizumab and hyaluronidase-ocsq	Roche
2024-09-12	FDA New indication	Dupixent	dupilumab	Regeneron	priority review
2024-09-12	FDA Other approval	Tecentriq Hybreza	atezolizumab and hyaluronidase-tqjs	Roche
2024-09-11	FDA New indication	Tremfya	guselkumab	J&J	priority review
2024-08-30	FDA New indication	Prevymis	letermovir	Merck	priority review
2024-08-30	FDA New indication	Prevymis	letermovir	Merck	priority review
2024-08-30	FDA New indication	Prevymis	letermovir	Merck	priority review
2024-08-30	FDA New indication	Prevymis	letermovir	Merck	priority review
2024-08-30	FDA Other approval	Prevymis	letermovir	Merck	priority review
2024-08-23	FDA Other approval	Pavblu	aflibercept-ayyh	Amgen
2024-08-22	EU Authorisation	Enzalutamide Viatris	enzalutamide	Viatris	generic
2024-08-22	EU Authorisation	mResvia	respiratory syncytial virus mRNA vaccine	Moderna
2024-08-22	EU Authorisation	Ordspono	odronextamab	Regeneron	conditionalorphan
2024-08-22	EU Authorisation	Tauvid	flortaucipir	Eli Lilly
2024-08-22	EU Authorisation	Piasky	crovalimab	Roche
2024-08-22	EU Authorisation	Winrevair	sotatercept	Merck	orphanprime
2024-08-22	FDA New indication	Beyfortus	nirsevimab-alip	AstraZeneca
2024-08-20	FDA New indication	Amjevita	adalimumab-atto	Amgen
2024-08-19	FDA New medicine	Lazcluze	lazertinib	J&J	priority review
2024-08-19	FDA New indication	Rybrevant	amivantamab-vmjw	J&J	priority review
2024-08-15	FDA New indication	Imfinzi	durvalumab	AstraZeneca
2024-08-14	FDA New medicine	Livdelzi	seladelpar lysine	Gilead	priority review
2024-08-14	FDA New medicine	Niktimvo	axatilimab-csfr	Incyte	priority review
2024-08-12	FDA New indication	Protonix Iv	pantoprazole	Pfizer
2024-08-08	FDA New indication	Vyvgart Hytrulo	efgartigimod alfa and hyaluronidase-qvfc	argenx
2024-08-08	FDA New indication	Vyvgart	efgartigimod alfa	argenx
2024-08-07	FDA New indication	Fabhalta	iptacopan	Novartis	priority review
2024-08-07	FDA New indication	Keytruda	pembrolizumab	Merck
2024-08-06	FDA New medicine	Voranigo	vorasidenib	Servier	priority review
2024-08-01	EU Authorisation	Adzynma	rADAMTS13	Takeda	exceptionalorphan
2024-08-01	FDA New indication	Jemperli	dostarlimab-gxly	GSK	priority review
2024-07-31	FDA New indication	Darzalex	daratumumab	J&J
2024-07-30	FDA New indication	Darzalex Faspro	daratumumab and hyaluronidase-fihj	J&J	priority review
2024-07-25	EU Positive opinion	Kayfanda	odevixibat	Ipsen	exceptional
2024-07-25	EU Positive opinion	Iqirvo	elafibranor	Ipsen	conditionalorphan
2024-07-25	EU Positive opinion	Vyloy	zolbetuximab	Astellas	orphan
2024-07-25	EU Positive opinion	Yuvanci	macitentan + tadalafil	J&J
2024-07-24	EU Authorisation	Zegalogue	dasiglucagon	Zealand
2024-07-24	EU Authorisation	Beqvez (previously Durveqtix)	fidanacogene elaparvovec	Pfizer	advanced_therapyconditionalprime
2024-07-24	FDA New indication	Brineura	cerliponase alfa	BioMarin
2024-07-22	FDA New indication	Kisqali	ribociclib	Novartis
2024-07-03	FDA Licence supplement	Esperoct	Antihemophilic Factor, GlycoPEGylated-exei	Novo Nordisk
2024-07-02	FDA New medicine	Kisunla	donanemab-azbt	Eli Lilly	priority review
2024-06-27	EU Positive opinion	Enzalutamide Viatris	enzalutamide	Viatris	generic
2024-06-27	EU Positive opinion	mResvia	respiratory syncytial virus mRNA vaccine	Moderna
2024-06-27	EU Positive opinion	Ordspono	odronextamab	Regeneron	conditionalorphan
2024-06-27	EU Positive opinion	Tauvid	flortaucipir	Eli Lilly
2024-06-27	EU Positive opinion	Piasky	crovalimab	Roche
2024-06-27	EU Positive opinion	Winrevair	sotatercept	Merck	orphanprime
2024-06-26	FDA New medicine	Ohtuvayre	ensifentrine	Merck
2024-06-26	FDA New indication	Vancomycin Hydrochloride	vancomycin	Viatris
2024-06-26	FDA New indication	Epkinly	epcoritamab-bysp	Genmab	priority review
2024-06-26	FDA New indication	Adakveo	crizanlizumab-tmca	Novartis
2024-06-21	FDA New indication	Sirturo	bedaquiline	J&J
2024-06-21	FDA New indication	Vyvgart Hytrulo	efgartigimod alfa and hyaluronidase-qvfc	argenx	priority review
2024-06-20	FDA New medicine	Piasky	crovalimab-akkz	Roche
2024-06-20	EU Authorisation	Wezenla	ustekinumab	Amgen	biosimilar
2024-06-20	EU Authorisation	Fruzaqla	fruquintinib	Takeda
2024-06-18	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2024-06-18	FDA New indication	Herceptin Hylecta	trastuzumab and hyaluronidase-oysk	Roche
2024-06-18	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2024-06-18	FDA New indication	Herceptin	trastuzumab	Roche
2024-06-17	FDA Vaccine / cell therapy	Capvaxive	Pneumococcal 21-valent Conjugate Vaccine	Merck
2024-06-17	EU Authorisation	Truqap	capivasertib	AstraZeneca
2024-06-17	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2024-06-14	FDA New indication	Imfinzi	durvalumab	AstraZeneca
2024-06-14	FDA New indication	Blincyto	blinatumomab	Amgen	priority review
2024-06-12	FDA New indication	Retevmo	selpercatinib	Eli Lilly
2024-06-12	FDA New indication	Retevmo	selpercatinib	Eli Lilly
2024-06-12	FDA New indication	Xigduo Xr	dapagliflozin + metformin	AstraZeneca	priority review
2024-06-12	FDA New indication	Farxiga	dapagliflozin	AstraZeneca	priority review
2024-06-10	FDA New medicine	Iqirvo	elafibranor	Ipsen	priority review
2024-06-10	FDA New indication	Kevzara	sarilumab	Sanofi
2024-06-07	FDA New indication	Lenvima	lenvatinib	Eisai
2024-06-07	FDA New indication	Keytruda	pembrolizumab	Merck
2024-06-03	EU Authorisation	Fluenz	influenza vaccine	AstraZeneca
2024-05-30	EU Positive opinion	Zegalogue	dasiglucagon	Zealand
2024-05-30	EU Positive opinion	Adzynma	rADAMTS13	Takeda	exceptionalorphan
2024-05-30	EU Positive opinion	Beqvez (previously Durveqtix)	fidanacogene elaparvovec	Pfizer	advanced_therapyconditionalprime
2024-05-29	EU Authorisation	Qalsody	tofersen	Biogen	exceptionalorphan
2024-05-29	FDA New indication	Retevmo	selpercatinib	Eli Lilly	priority review
2024-05-28	FDA Other approval	Bkemv	eculizumab-aeeb	Amgen
2024-05-21	EU Positive opinion	Fluenz	influenza vaccine	AstraZeneca
2024-05-17	EU Authorisation	Awiqli	insulin icodec	Novo Nordisk
2024-05-17	EU Authorisation	Fabhalta	iptacopan	Novartis	orphanprime
2024-05-16	FDA New medicine	Imdelltra	tarlatamab-dlle	Amgen	priority review
2024-05-16	FDA New indication	Benlysta	belimumab	GSK
2024-05-07	FDA New indication	Rexulti	brexpiprazole	Otsuka	priority review
2024-04-30	FDA New indication	Cyltezo	adalimumab-adbm	Boehringer Ingelheim
2024-04-30	FDA New indication	Mircera	methoxy polyethylene glycol-epoetin beta	Roche
2024-04-30	FDA Other approval	Ingrezza Sprinkle	valbenazine	Neurocrine Biosciences
2024-04-29	FDA New indication	Tivdak	tisotumab vedotin-tftv	Pfizer	priority review
2024-04-26	FDA New indication	Rinvoq	upadacitinib	AbbVie
2024-04-26	FDA New indication	Rinvoq	upadacitinib	AbbVie
2024-04-26	FDA Other approval	Rinvoq Lq	upadacitinib	AbbVie
2024-04-25	FDA Vaccine / cell therapy	Beqvez	fidanacogene elaparvovec-dzkt	Pfizer
2024-04-25	EU Positive opinion	Wezenla	ustekinumab	Amgen	biosimilar
2024-04-25	EU Positive opinion	Truqap	capivasertib	AstraZeneca
2024-04-25	EU Positive opinion	Fruzaqla	fruquintinib	Takeda
2024-04-25	FDA New indication	Otezla	apremilast	Amgen	priority review
2024-04-24	FDA New indication	Vijoice	alpelisib	Novartis
2024-04-24	FDA New indication	Biktarvy	bictegravir + emtricitabine +1 more	Gilead	priority review
2024-04-24	FDA Other approval	Vijoice	alpelisib	Novartis
2024-04-22	EU Authorisation	Dimethyl fumarate Mylan	dimethyl	Viatris	generic
2024-04-22	EU Authorisation	Emblaveo	aztreonam + avibactam	Pfizer
2024-04-19	EU Authorisation	Zynyz	retifanlimab	Incyte	orphan
2024-04-19	EU Authorisation	Celldemic	zoonotic influenza vaccine	CSL
2024-04-19	EU Authorisation	Incellipan	pandemic influenza vaccine	CSL	conditional
2024-04-19	EU Authorisation	Voydeya	danicopan	AstraZeneca	orphanprime
2024-04-18	FDA New indication	Alecensa	alectinib	Roche	priority review
2024-04-18	FDA Other approval	Entyvio	vedolizumab	Takeda
2024-04-12	FDA New indication	Entresto	sacubitril + valsartan	Novartis
2024-04-12	FDA Other approval	Entresto Sprinkle	sacubitril + valsartan	Novartis
2024-04-10	FDA Other approval	Retevmo	selpercatinib	Eli Lilly
2024-04-05	FDA New indication	Dovato	dolutegravir + lamivudine	GSK
2024-04-05	FDA New indication	Dovato	dolutegravir + lamivudine	GSK
2024-04-05	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2024-04-05	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron
2024-04-05	FDA New indication	Fasenra	benralizumab	AstraZeneca
2024-04-04	FDA Licence supplement	Abecma	idecabtagene vicleucel	BMS
2024-04-03	FDA New indication	Lenvima	lenvatinib	Eisai	priority review
2024-03-29	FDA New medicine	Voydeya	danicopan	AstraZeneca
2024-03-27	FDA New indication	Vemlidy	tenofovir alafenamide	Gilead	priority review
2024-03-27	FDA New indication	Vemlidy	tenofovir alafenamide	Gilead
2024-03-26	FDA New medicine	Winrevair	sotatercept-csrk	Merck	priority review
2024-03-22	FDA New indication	Brilinta	ticagrelor	AstraZeneca
2024-03-22	FDA New indication	Ultomiris	ravulizumab-cwvz	AstraZeneca
2024-03-22	FDA Other approval	Opsynvi	macitentan + tadalafil	J&J
2024-03-21	EU Positive opinion	Dimethyl fumarate Mylan	dimethyl	Viatris	generic
2024-03-21	EU Positive opinion	Emblaveo	aztreonam + avibactam	Pfizer
2024-03-21	EU Positive opinion	Awiqli	insulin icodec	Novo Nordisk
2024-03-21	EU Positive opinion	Fabhalta	iptacopan	Novartis	orphanprime
2024-03-19	FDA New indication	Iclusig	ponatinib	Takeda	priority review
2024-03-18	FDA New indication	Spevigo	spesolimab-sbzo	Boehringer Ingelheim
2024-03-15	FDA New indication	Edurant	rilpivirine	J&J	priority review
2024-03-15	FDA New indication	Edurant	rilpivirine	J&J	priority review
2024-03-15	FDA New indication	Increlex	mecasermin recombinant	Ipsen
2024-03-15	FDA Other approval	Edurant Ped	rilpivirine	J&J	priority review
2024-03-08	FDA New indication	Wegovy, Wegovy Flextouch	semaglutide	Novo Nordisk	priority review
2024-03-08	FDA New indication	Praluent	alirocumab	Regeneron
2024-03-07	FDA New indication	Caprelsa	vandetanib	Sanofi
2024-03-07	FDA Other approval	Talzenna	talazoparib	Pfizer
2024-03-06	FDA New indication	Besponsa	inotuzumab ozogamicin	Pfizer	priority review
2024-03-06	FDA New indication	Opdivo	nivolumab	BMS	priority review
2024-03-05	FDA New indication	Prolia, Xgeva	denosumab	Amgen
2024-03-04	FDA Licence supplement	Flucelvax, Flucelvax Quadrivalent	Influenza Vaccine	CSL
2024-03-01	FDA New indication	Xofluza	baloxavir marboxil	Roche
2024-03-01	FDA New indication	Xofluza	baloxavir marboxil	Roche
2024-03-01	FDA New indication	Rybrevant	amivantamab-vmjw	J&J	priority review
2024-02-28	FDA New indication	Veklury	remdesivir	Gilead	priority review
2024-02-23	FDA New indication	Biktarvy	bictegravir + emtricitabine +1 more	Gilead
2024-02-22	EU Positive opinion	Zynyz	retifanlimab	Incyte	orphan
2024-02-22	EU Positive opinion	Celldemic	zoonotic influenza vaccine	CSL
2024-02-22	EU Positive opinion	Incellipan	pandemic influenza vaccine	CSL	conditional
2024-02-22	EU Positive opinion	Voydeya	danicopan	AstraZeneca	orphanprime
2024-02-22	EU Positive opinion	Qalsody	tofersen	Biogen	exceptionalorphan
2024-02-20	FDA New indication	Tecvayli	teclistamab-cqyv	J&J
2024-02-19	EU Authorisation	Dabigatran etexilate Teva (previously Dabigatran etexilate Leon Farma)	dabigatran etexilate	Teva	generic
2024-02-16	EU Authorisation	Pomalidomide Viatris	pomalidomide	Viatris	generic
2024-02-16	EU Authorisation	Velsipity	etrasimod	Pfizer
2024-02-16	FDA New indication	Tagrisso	osimertinib	AstraZeneca	priority review
2024-02-16	FDA New indication	Xolair	omalizumab	Roche	priority review
2024-02-15	FDA New indication	Tepmetko	tepotinib	Merck KGaA
2024-02-15	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo
2024-02-13	FDA New indication	Onivyde	irinotecan	Ipsen
2024-02-09	EU Authorisation	Skyclarys	omaveloxolone	Biogen	orphan
2024-02-09	EU Authorisation	Casgevy	exagamglogene autotemcel	Vertex	advanced_therapyconditionalorphanprime
2024-02-09	FDA Other approval	Eohilia	budesonide	Takeda	priority review
2024-01-31	FDA New indication	Tagrisso	osimertinib	AstraZeneca
2024-01-26	FDA New indication	Avycaz	avibactam + ceftazidime	AbbVie	priority review
2024-01-26	FDA New indication	Opdivo	nivolumab	BMS
2024-01-25	EU Authorisation	Omjjara	momelotinib	GSK	orphan
2024-01-25	FDA New indication	Dupixent	dupilumab	Regeneron	priority review
2024-01-25	FDA New indication	Keytruda	pembrolizumab	Merck
2024-01-24	FDA New indication	Koselugo	selumetinib	AstraZeneca
2024-01-19	FDA New indication	Balversa	erdafitinib	J&J	priority review
2024-01-19	FDA New indication	Balversa	erdafitinib	J&J	priority review
2024-01-18	FDA New indication	Piqray	alpelisib	Novartis	priority review
2024-01-12	FDA New indication	Dupixent	dupilumab	Regeneron
2024-01-12	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2024-01-05	EU Authorisation	Krazati	adagrasib	BMS	conditional
2024-01-05	EU Authorisation	Spexotras	trametinib	Novartis	orphan
2024-01-05	EU Authorisation	Rystiggo	rozanolixizumab	UCB	orphan
2023-12-21	FDA New medicine	Wainua, Wainua (Autoinjector)	eplontersen	AstraZeneca
2023-12-19	FDA New indication	Erleada	apalutamide	J&J
2023-12-18	FDA New medicine	Filsuvez	birch triterpenes	Chiesi	priority review
2023-12-15	FDA New indication	Padcev	enfortumab vedotin-ejfv	Astellas	priority review
2023-12-15	FDA New indication	Padcev	enfortumab vedotin-ejfv	Astellas	priority review
2023-12-15	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2023-12-15	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2023-12-14	EU Positive opinion	Pomalidomide Viatris	pomalidomide	Viatris	generic
2023-12-14	EU Positive opinion	Skyclarys	omaveloxolone	Biogen	orphan
2023-12-14	EU Positive opinion	Velsipity	etrasimod	Pfizer
2023-12-14	EU Positive opinion	Casgevy	exagamglogene autotemcel	Vertex	advanced_therapyconditionalorphanprime
2023-12-14	FDA New indication	Welireg	belzutifan	Merck	priority review
2023-12-14	FDA New indication	Cibinqo	abrocitinib	Pfizer
2023-12-08	FDA Vaccine / cell therapy	Casgevy	Exagamglogene autotemcel	Vertex
2023-12-08	FDA New indication	Cresemba	isavuconazonium	Astellas	priority review
2023-12-08	FDA New indication	Cresemba	isavuconazonium	Astellas	priority review
2023-12-07	EU Authorisation	Elrexfio	elranatamab	Pfizer	conditionalprime
2023-12-07	EU Authorisation	Veoza	fezolinetant	Astellas
2023-12-05	FDA New medicine	Fabhalta	iptacopan	Novartis	priority review
2023-12-01	EU Authorisation	Zilbrysq	zilucoplan	UCB
2023-12-01	FDA New indication	Saphnelo	anifrolumab-fnia	AstraZeneca
2023-11-29	FDA Other approval	Alvaiz	eltrombopag choline	Teva
2023-11-21	FDA New indication	Paclitaxel	paclitaxel	Teva
2023-11-16	FDA New medicine	Truqap	capivasertib	AstraZeneca	priority review
2023-11-16	FDA New indication	Xtandi	enzalutamide	Astellas	priority review
2023-11-16	FDA New indication	Xtandi	enzalutamide	Astellas	priority review
2023-11-16	FDA New indication	Keytruda	pembrolizumab	Merck
2023-11-15	EU Authorisation	Finlee	dabrafenib	Novartis	orphan
2023-11-14	EU Positive opinion	Xelevia	sitagliptin	Merck
2023-11-09	FDA Vaccine / cell therapy	Adzynma	ADAMTS13, recombinant-krhn	Takeda
2023-11-09	EU Positive opinion	Krazati	adagrasib	BMS	conditional
2023-11-09	EU Positive opinion	Spexotras	trametinib	Novartis	orphan
2023-11-09	EU Positive opinion	Rystiggo	rozanolixizumab	UCB	orphan
2023-11-09	EU Positive opinion	Omjjara	momelotinib	GSK	orphan
2023-11-08	FDA New medicine	Fruzaqla	fruquintinib	Takeda	priority review
2023-11-08	FDA Other approval	Zepbound, Zepbound (Autoinjector)	tirzepatide	Eli Lilly	priority review
2023-11-07	FDA New indication	Keytruda	pembrolizumab	Merck
2023-11-06	EU Authorisation	Vanflyta	quizartinib	Daiichi Sankyo
2023-11-06	FDA New indication	Lynparza	olaparib	AstraZeneca
2023-11-01	FDA New indication	Sarclisa	isatuximab-irfc	Sanofi
2023-10-31	FDA New indication	Keytruda	pembrolizumab	Merck
2023-10-31	FDA New indication	Keytruda	pembrolizumab	Merck
2023-10-31	FDA New indication	Cosentyx	secukinumab	Novartis
2023-10-31	FDA Other approval	Wezlana	ustekinumab-auub	Amgen
2023-10-31	FDA Other approval	Wezlana	ustekinumab-auub	Amgen
2023-10-30	EU Authorisation	Jaypirca	pirtobrutinib	Eli Lilly	conditional
2023-10-30	FDA New indication	Orencia	abatacept	BMS
2023-10-26	FDA New medicine	Omvoh	mirikizumab-mrkz	Eli Lilly
2023-10-26	FDA New indication	Vabysmo	faricimab-svoa	Roche
2023-10-24	FDA New indication	Tibsovo	ivosidenib	Servier	priority review
2023-10-23	FDA New indication	Lenvima	lenvatinib	Eisai
2023-10-23	FDA New indication	Multaq	dronedarone	Sanofi
2023-10-23	FDA New indication	Keytruda	pembrolizumab	Merck
2023-10-20	FDA Vaccine / cell therapy	Penbraya	Meningococcal Groups A, B, C, W, and Y Vaccine	Pfizer
2023-10-20	FDA New indication	Voxzogo	vosoritide	BioMarin
2023-10-20	FDA New indication	Rozlytrek	entrectinib	Roche	priority review
2023-10-20	FDA New indication	Epidiolex	cannabidiol	Jazz
2023-10-20	FDA Other approval	Rozlytrek	entrectinib	Roche	priority review
2023-10-18	FDA New indication	Savaysa	edoxaban	Daiichi Sankyo
2023-10-18	FDA New indication	Savaysa	edoxaban	Daiichi Sankyo
2023-10-17	FDA New medicine	Zilbrysq	zilucoplan	UCB
2023-10-17	FDA New medicine	Bimzelx	bimekizumab-bkzx	UCB
2023-10-17	FDA Licence supplement	Comirnaty	COVID-19 Vaccine, mRNA	BioNTech
2023-10-16	FDA New indication	Keytruda	pembrolizumab	Merck
2023-10-13	FDA New indication	Opdivo	nivolumab	BMS
2023-10-12	FDA New medicine	Velsipity	etrasimod arginine	Pfizer
2023-10-12	EU Positive opinion	Elrexfio	elranatamab	Pfizer	conditionalprime
2023-10-12	EU Positive opinion	Veoza	fezolinetant	Astellas
2023-10-12	FDA New indication	Keytruda	pembrolizumab	Merck
2023-10-09	EU Authorisation	Zoonotic Influenza Vaccine Seqirus	zoonotic influenza vaccine	CSL
2023-10-06	FDA Other approval	Cosentyx	secukinumab	Novartis
2023-10-04	FDA New indication	Abrilada	adalimumab-afzb	Pfizer
2023-10-03	FDA New indication	Evrysdi	risdiplam	Roche
2023-09-29	FDA New medicine	Rivfloza	nedosiran	Novo Nordisk
2023-09-29	FDA Other approval	Tofidence	tocilizumab-bavi	Biogen
2023-09-27	FDA Other approval	Entyvio	vedolizumab	Takeda
2023-09-22	EU Authorisation	Tepkinly	epcoritamab	AbbVie	conditional
2023-09-21	FDA New indication	Jardiance	empagliflozin	Boehringer Ingelheim
2023-09-15	FDA New medicine	Ojjaara	momelotinib dihydrochloride	GSK
2023-09-15	EU Authorisation	Litfulo	ritlecitinib	Pfizer
2023-09-15	EU Authorisation	Enrylaze	crisantaspase	Jazz
2023-09-15	EU Authorisation	Inaqovi	cedazuridine + decitabine	Otsuka
2023-09-15	EU Authorisation	Apretude	cabotegravir	GSK
2023-09-15	EU Authorisation	Lyfnua	gefapixant	Merck
2023-09-15	FDA New indication	Nexviazyme	avalglucosidase alfa-ngpt	Sanofi
2023-09-14	EU Positive opinion	Vanflyta	quizartinib	Daiichi Sankyo
2023-09-14	EU Positive opinion	Finlee	dabrafenib	Novartis	orphan
2023-09-14	EU Positive opinion	Zilbrysq	zilucoplan	UCB
2023-09-14	FDA New indication	Temodar	temozolomide	Merck
2023-09-14	FDA New indication	Temodar	temozolomide	Merck
2023-09-14	FDA New indication	Temodar	temozolomide	Merck
2023-09-14	FDA New indication	Temodar	temozolomide	Merck
2023-09-14	FDA New indication	Temodar	temozolomide	Merck
2023-09-14	FDA New indication	Temodar	temozolomide	Merck
2023-09-07	EU Positive opinion	Enerzair Breezhaler	indacaterol + glycopyrronium +1 more	Novartis
2023-09-06	FDA New indication	Ibrance	palbociclib	Pfizer
2023-09-06	FDA New indication	Ibrance	palbociclib	Pfizer
2023-09-06	FDA New indication	Bavencio	avelumab	Merck KGaA
2023-08-31	FDA New indication	Mekinist	trametinib dimethyl sulfoxide	Novartis	priority review
2023-08-31	FDA New indication	Tafinlar	dabrafenib	Novartis	priority review
2023-08-28	FDA New indication	Reblozyl	luspatercept-aamt	BMS	priority review
2023-08-25	FDA New indication	Ilaris	canakinumab	Novartis
2023-08-23	EU Authorisation	Abrysvo	respiratory syncytial virus vaccine	Pfizer	accelerated
2023-08-23	FDA New indication	Trintellix	vortioxetine	Takeda	priority review
2023-08-23	FDA Licence supplement	Comirnaty	COVID-19 Vaccine, mRNA	BioNTech
2023-08-18	FDA New medicine	Veopoz	pozelimab-bbfg	Regeneron	priority review
2023-08-18	FDA New indication	Ingrezza	valbenazine	Neurocrine Biosciences
2023-08-18	FDA Other approval	Eylea Hd	aflibercept	Regeneron	priority review
2023-08-16	FDA New medicine	Sohonos	palovarotene	Ipsen	priority review
2023-08-14	FDA New medicine	Elrexfio	elranatamab	Pfizer	priority review
2023-08-14	EU Positive opinion	Azilect	rasagiline	Teva
2023-08-14	FDA New indication	Amjevita	adalimumab-atto	Amgen
2023-08-14	FDA New indication	Keytruda	pembrolizumab	Merck
2023-08-14	FDA New indication	Keytruda	pembrolizumab	Merck
2023-08-11	EU Authorisation	Aquipta	atogepant	AbbVie
2023-08-11	FDA New indication	Botox, Botox Cosmetic	OnabotulinumtoxinA	AbbVie
2023-08-11	FDA Other approval	Akeega	abiraterone + niraparib	J&J	priority review
2023-08-09	FDA New medicine	Talvey	talquetamab-tgvs	J&J	priority review
2023-08-04	FDA New medicine	Zurzuvae	zuranolone	Biogen	priority review
2023-08-04	FDA New medicine	Izervay	avacincaptad pegol	Astellas	priority review
2023-08-02	FDA New indication	Prevymis	letermovir	Merck
2023-08-02	FDA New indication	Prevymis	letermovir	Merck
2023-07-31	FDA New indication	Jemperli	dostarlimab-gxly	GSK	priority review
2023-07-27	FDA New indication	Kazano	alogliptin benzoate + metformin	Takeda
2023-07-27	FDA New indication	Nesina	alogliptin benzoate	Takeda
2023-07-27	FDA New indication	Somavert	pegvisomant	Pfizer
2023-07-21	FDA New indication	Wegovy, Wegovy Flextouch	semaglutide	Novo Nordisk
2023-07-20	FDA New medicine	Vanflyta	quizartinib dihydrochloride	Daiichi Sankyo	priority review
2023-07-20	EU Positive opinion	Abrysvo	respiratory syncytial virus vaccine	Pfizer	accelerated
2023-07-20	EU Positive opinion	Litfulo	ritlecitinib	Pfizer
2023-07-20	EU Positive opinion	Tepkinly	epcoritamab	AbbVie	conditional
2023-07-20	EU Positive opinion	Enrylaze	crisantaspase	Jazz
2023-07-20	EU Positive opinion	Inaqovi	cedazuridine + decitabine	Otsuka
2023-07-20	EU Positive opinion	Apretude	cabotegravir	GSK
2023-07-20	EU Positive opinion	Lyfnua	gefapixant	Merck
2023-07-20	FDA New indication	Otezla	apremilast	Amgen
2023-07-17	FDA New medicine	Beyfortus	nirsevimab-alip	AstraZeneca
2023-07-17	EU Refusal	Sohonos	palovarotene	Ipsen	orphan
2023-07-13	FDA New indication	Veklury	remdesivir	Gilead	priority review
2023-07-07	EU Authorisation	Columvi	glofitamab	Roche
2023-07-06	FDA New indication	Leqembi	lecanemab-irmb	Eisai	priority review
2023-06-30	FDA New indication	Cyltezo	adalimumab-adbm	Boehringer Ingelheim
2023-06-29	FDA Vaccine / cell therapy	Roctavian	valoctocogene roxaparvovec-rvox	BioMarin
2023-06-27	FDA New medicine	Ngenla	somatrogon-ghla	Pfizer
2023-06-26	FDA New medicine	Rystiggo	rozanolixizumab-noli	UCB	priority review
2023-06-26	EU Authorisation	Camzyos	mavacamten	BMS
2023-06-23	FDA New medicine	Litfulo	ritlecitinib	Pfizer
2023-06-22	FDA Vaccine / cell therapy	Elevidys	delandistrogene moxeparvovec-rokl	Sarepta
2023-06-22	EU Positive opinion	Aquipta	atogepant	AbbVie
2023-06-22	FDA New indication	Rinvoq	upadacitinib	AbbVie
2023-06-20	FDA New indication	Talzenna	talazoparib	Pfizer	priority review
2023-06-20	FDA New indication	Synjardy Xr	empagliflozin + metformin	Boehringer Ingelheim	priority review
2023-06-20	FDA New indication	Jentadueto Xr	linagliptin + metformin	Boehringer Ingelheim	priority review
2023-06-20	FDA New indication	Synjardy	empagliflozin + metformin	Boehringer Ingelheim	priority review
2023-06-20	FDA New indication	Jardiance	empagliflozin	Boehringer Ingelheim	priority review
2023-06-20	FDA New indication	Jentadueto	linagliptin + metformin	Boehringer Ingelheim	priority review
2023-06-20	FDA New indication	Tradjenta	linagliptin	Boehringer Ingelheim	priority review
2023-06-20	FDA New indication	Blincyto	blinatumomab	Amgen
2023-06-20	FDA New indication	Blincyto	blinatumomab	Amgen	priority review
2023-06-20	FDA Other approval	Vyvgart Hytrulo	efgartigimod alfa and hyaluronidase-qvfc	argenx	priority review
2023-06-15	FDA New medicine	Columvi	glofitamab-gxbm	Roche	priority review
2023-06-15	FDA New indication	Triumeq Pd	abacavir + dolutegravir +1 more	GSK	priority review
2023-06-15	FDA New indication	Triumeq	abacavir + dolutegravir +1 more	GSK	priority review
2023-06-14	FDA New indication	Abrilada	adalimumab-afzb	Pfizer
2023-06-13	FDA New indication	Bylvay	odevixibat	Ipsen	priority review
2023-06-12	FDA New indication	Linzess	linaclotide	AbbVie	priority review
2023-06-06	EU Authorisation	Arexvy	Respiratory Syncytial Virus vaccine	GSK
2023-06-05	FDA New indication	Prevymis	letermovir	Merck	priority review
2023-06-05	FDA New indication	Prevymis	letermovir	Merck	priority review
2023-06-02	FDA New indication	Lampit	nifurtimox	Bayer
2023-05-31	FDA Vaccine / cell therapy	Abrysvo	Respiratory Syncytial Virus Vaccine	Pfizer
2023-05-31	FDA New indication	Lynparza	olaparib	AstraZeneca	priority review
2023-05-26	EU Authorisation	Omvoh	mirikizumab	Eli Lilly
2023-05-26	FDA New indication	Zinplava	bezlotoxumab	Merck	priority review
2023-05-25	FDA New medicine	Paxlovid (Copackaged)	nirmatrelvir + ritonavir	Pfizer	priority review
2023-05-25	FDA New indication	Ultravist (Pharmacy Bulk)	iopromide	Bayer
2023-05-25	FDA New indication	Ultravist 150, Ultravist 240	iopromide	Bayer
2023-05-19	FDA New medicine	Epkinly	epcoritamab-bysp	Genmab	priority review
2023-05-18	FDA New indication	Rinvoq	upadacitinib	AbbVie
2023-05-18	FDA New indication	Imbruvica	ibrutinib	AbbVie
2023-05-18	FDA New indication	Imbruvica	ibrutinib	AbbVie
2023-05-18	FDA New indication	Cyltezo	adalimumab-adbm	Boehringer Ingelheim
2023-05-12	FDA New medicine	Veozah	fezolinetant	Astellas	priority review
2023-05-12	FDA New indication	Lexapro	escitalopram	AbbVie
2023-05-12	FDA New indication	Lexapro	escitalopram	AbbVie
2023-05-11	FDA New indication	Cosentyx	secukinumab	Novartis
2023-05-11	FDA Other approval	Paclitaxel	paclitaxel	Teva
2023-05-10	FDA New indication	Rexulti	brexpiprazole	Otsuka	priority review
2023-05-09	FDA New medicine	Elfabrio	pegunigalsidase alfa-iwxj	Chiesi	priority review
2023-05-08	FDA New indication	Farxiga	dapagliflozin	AstraZeneca
2023-05-04	EU Authorisation	Tibsovo	ivosidenib	Servier	orphan
2023-05-04	EU Authorisation	Elfabrio	pegunigalsidase alfa	Chiesi
2023-05-03	FDA Vaccine / cell therapy	Arexvy	Respiratory Syncytial Virus Vaccine, Adjuvanted	GSK
2023-05-03	FDA New indication	Kalydeco	ivacaftor	Vertex	priority review
2023-04-28	FDA New indication	Vimpat	lacosamide	UCB
2023-04-28	FDA New indication	Vimpat	lacosamide	UCB
2023-04-28	FDA New indication	Vimpat	lacosamide	UCB
2023-04-28	FDA New indication	Sogroya	somapacitan-beco	Novo Nordisk
2023-04-28	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron
2023-04-28	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron
2023-04-28	FDA Other approval	Symbicort Aerosphere	budesonide + formoterol	AstraZeneca
2023-04-28	FDA Other approval	Uzedy	risperidone	Teva
2023-04-27	FDA Other approval	Abilify Asimtufii	aripiprazole	Otsuka
2023-04-26	EU Positive opinion	Arexvy	Respiratory Syncytial Virus vaccine	GSK
2023-04-26	EU Positive opinion	Jaypirca	pirtobrutinib	Eli Lilly	conditional
2023-04-26	EU Positive opinion	Columvi	glofitamab	Roche
2023-04-26	FDA New indication	Zejula	niraparib	GSK
2023-04-26	FDA Other approval	Trikafta (Copackaged)	elexacaftor, ivacaftor, tezacaftor + ivacaftor	Vertex	priority review
2023-04-26	FDA Other approval	Zejula	niraparib	GSK
2023-04-25	FDA New medicine	Qalsody	tofersen	Biogen	priority review
2023-04-20	FDA New indication	Dayvigo	lemborexant	Eisai
2023-04-19	EU Authorisation	Opzelura	ruxolitinib	Incyte
2023-04-19	EU Authorisation	Bekemv	eculizumab	Amgen	biosimilar
2023-04-19	FDA New indication	Polivy	polatuzumab vedotin-piiq	Roche
2023-04-17	FDA New indication	Qulipta	atogepant	AbbVie
2023-04-14	FDA New indication	Lupron Depot-Ped Kit	leuprolide	AbbVie
2023-04-13	FDA Licence supplement	Hizentra	Immune Globulin Subcutaneous, 20% Liquid	CSL
2023-04-13	FDA Licence supplement	Hizentra	Immune Globulin Subcutaneous, 20% Liquid	CSL
2023-04-13	FDA Licence supplement	Hizentra	Immune Globulin Subcutaneous, 20% Liquid	CSL
2023-04-03	FDA New indication	Padcev	enfortumab vedotin-ejfv	Astellas	priority review
2023-04-03	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2023-03-31	FDA New indication	Mircera	methoxy polyethylene glycol-epoetin beta	Roche
2023-03-30	EU Positive opinion	Omvoh	mirikizumab	Eli Lilly
2023-03-28	FDA New indication	Vuity	pilocarpine	AbbVie
2023-03-28	FDA New indication	Keytruda	pembrolizumab	Merck
2023-03-24	EU Authorisation	Dapagliflozin Viatris	dapagliflozin	Viatris	generic
2023-03-24	EU Authorisation	Sotyktu	deucravacitinib	BMS
2023-03-24	FDA New indication	Fetzima	levomilnacipran	AbbVie
2023-03-22	FDA New medicine	Zynyz	retifanlimab-dlwr	Incyte	priority review
2023-03-22	FDA New indication	Cyltezo	adalimumab-adbm	Boehringer Ingelheim
2023-03-22	FDA New indication	Amjevita	adalimumab-atto	Amgen
2023-03-21	FDA New indication	Evkeeza	evinacumab-dgnb	Regeneron	priority review
2023-03-16	FDA New indication	Mekinist	trametinib dimethyl sulfoxide	Novartis	priority review
2023-03-16	FDA New indication	Tafinlar	dabrafenib	Novartis	priority review
2023-03-16	FDA Other approval	Tafinlar	dabrafenib	Novartis	priority review
2023-03-16	FDA Other approval	Mekinist	trametinib + trametinib dimethyl sulfoxide	Novartis	priority review
2023-03-09	FDA New medicine	Zavzpret	zavegepant	Pfizer
2023-03-03	FDA New indication	Verzenio	abemaciclib	Eli Lilly
2023-03-03	FDA New indication	Verzenio	abemaciclib	Eli Lilly
2023-03-03	FDA New indication	Revatio	sildenafil	Viatris
2023-03-03	FDA New indication	Revatio	sildenafil	Viatris
2023-03-01	FDA New indication	Arnuity Ellipta	fluticasone furoate	GSK
2023-02-28	FDA New medicine	Skyclarys	omaveloxolone	Biogen	priority review
2023-02-28	FDA New indication	Kevzara	sarilumab	Sanofi	priority review
2023-02-27	FDA Licence supplement	Proquad	Measles, Mumps, Rubella and Varicella Virus Vaccine Live	Merck
2023-02-27	FDA Licence supplement	Varivax	Varicella Virus Vaccine Live	Merck
2023-02-27	FDA Licence supplement	M-M-R Ii	Measles, Mumps and Rubella Virus Vaccine Live	Merck
2023-02-23	EU Positive opinion	Tibsovo	ivosidenib	Servier	orphan
2023-02-23	EU Positive opinion	Opzelura	ruxolitinib	Incyte
2023-02-23	EU Positive opinion	Bekemv	eculizumab	Amgen	biosimilar
2023-02-23	EU Positive opinion	Elfabrio	pegunigalsidase alfa	Chiesi
2023-02-20	EU Authorisation	Imjudo	tremelimumab	AstraZeneca
2023-02-20	EU Authorisation	Hemgenix	etranacogene dezaparvovec	CSL	advanced_therapyconditionalorphanprime
2023-02-20	EU Authorisation	Tremelimumab AstraZeneca	tremelimumab	AstraZeneca
2023-02-17	FDA Other approval	Austedo Xr	deutetrabenazine	Teva
2023-02-16	FDA New medicine	Lamzede	velmanase alfa-tycv	Chiesi	priority review
2023-02-15	FDA New indication	Benlysta	belimumab	GSK
2023-02-15	FDA New indication	Opdivo	nivolumab	BMS	priority review
2023-02-15	FDA New indication	Opdivo	nivolumab	BMS	priority review
2023-02-15	FDA New indication	Opdivo	nivolumab	BMS	priority review
2023-02-15	FDA New indication	Yervoy	ipilimumab	BMS	priority review
2023-02-10	FDA New indication	Vumerity	diroximel	Biogen
2023-02-10	FDA New indication	Tecfidera	dimethyl	Biogen
2023-02-09	FDA New indication	Cibinqo	abrocitinib	Pfizer	priority review
2023-02-09	FDA New indication	Jemperli	dostarlimab-gxly	GSK
2023-02-09	FDA New indication	Jemperli	dostarlimab-gxly	GSK
2023-02-08	FDA New indication	Aduhelm	aducanumab-avwa	Biogen
2023-02-08	FDA New indication	Eylea	aflibercept	Regeneron	priority review
2023-02-06	FDA New indication	Synjardy Xr	empagliflozin + metformin	Boehringer Ingelheim
2023-02-06	FDA New indication	Synjardy	empagliflozin + metformin	Boehringer Ingelheim
2023-02-01	FDA New medicine	Jesduvroq	daprodustat	GSK
2023-02-01	FDA New indication	Tezspire	tezepelumab-ekko	AstraZeneca
2023-01-31	FDA New indication	Revatio	sildenafil	Viatris
2023-01-27	FDA New indication	Vabysmo	faricimab-svoa	Roche
2023-01-26	EU Positive opinion	Dapagliflozin Viatris	dapagliflozin	Viatris	generic
2023-01-26	EU Positive opinion	Sotyktu	deucravacitinib	BMS
2023-01-26	FDA New indication	Keytruda	pembrolizumab	Merck
2023-01-25	FDA New indication	Dovato	dolutegravir + lamivudine	GSK
2023-01-25	FDA New indication	Enjaymo	sutimlimab-jome	Recordati	priority review
2023-01-25	FDA New indication	Entyvio	vedolizumab	Takeda
2023-01-19	FDA New indication	Tukysa	tucatinib	Pfizer	priority review
2023-01-19	FDA New indication	Darzalex	daratumumab	J&J
2023-01-13	FDA New indication	Onpattro	patisiran	Alnylam
2023-01-12	FDA New indication	Dysport	abobotulinumtoxinA	Ipsen
2023-01-10	EU Authorisation	Pirfenidone Viatris	pirfenidone	Viatris	generic
2023-01-10	FDA Other approval	Airsupra	albuterol + budesonide	AstraZeneca
2023-01-06	FDA New medicine	Leqembi	lecanemab-irmb	Eisai	priority review
2022-12-23	FDA New indication	Wegovy, Wegovy Flextouch	semaglutide	Novo Nordisk	priority review
2022-12-22	FDA New medicine	Sunlenca	lenacapavir	Gilead	priority review
2022-12-22	FDA New medicine	Sunlenca	lenacapavir	Gilead	priority review
2022-12-22	FDA New medicine	Lunsumio, Lunsumio Velo	mosunetuzumab-axgb	Roche	priority review
2022-12-22	FDA New indication	Cimzia	certolizumab pegol	UCB
2022-12-21	FDA New indication	Actemra	tocilizumab	Roche	priority review
2022-12-20	FDA New indication	Avycaz	avibactam + ceftazidime	AbbVie	priority review
2022-12-19	FDA New indication	Jakafi	ruxolitinib	Incyte	priority review
2022-12-16	FDA New indication	Vraylar	cariprazine	AbbVie
2022-12-16	FDA New indication	Precedex	dexmedetomidine	Pfizer
2022-12-16	FDA New indication	Keytruda	pembrolizumab	Merck
2022-12-15	EU Positive opinion	Imjudo	tremelimumab	AstraZeneca
2022-12-15	EU Positive opinion	Hemgenix	etranacogene dezaparvovec	CSL	advanced_therapyconditionalorphanprime
2022-12-15	EU Positive opinion	Tremelimumab AstraZeneca	tremelimumab	AstraZeneca
2022-12-15	FDA Other approval	Bendamustine Hydrochloride	bendamustine	Pfizer
2022-12-13	FDA New indication	Ibrance	palbociclib	Pfizer
2022-12-13	FDA New indication	Ibrance	palbociclib	Pfizer
2022-12-12	EU Authorisation	Dimethyl fumarate Teva	dimethyl	Teva	generic
2022-12-09	EU Authorisation	Locametz	gozetotide	Novartis
2022-12-09	EU Authorisation	Pluvicto	lutetium vipivotide tetraxetan	Novartis
2022-12-09	FDA New indication	Bortezomib	bortezomib	Pfizer
2022-12-09	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2022-12-08	FDA New indication	Zejula	niraparib	GSK
2022-12-05	EU Authorisation	Qdenga	dengue tetravalent vaccine	Takeda
2022-12-02	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2022-11-30	FDA New indication	Brexafemme	ibrexafungerp	GSK	priority review
2022-11-29	FDA Licence supplement	Albutein	Albumin	Grifols
2022-11-22	FDA Vaccine / cell therapy	Hemgenix	etranacogene dezaparvovec-drlb	CSL
2022-11-22	FDA New indication	Piqray	alpelisib	Novartis
2022-11-18	FDA New indication	Rylaze	asparaginase erwinia chrysanthemi-rywn	Jazz
2022-11-17	FDA New indication	Trulicity	dulaglutide	Eli Lilly	priority review
2022-11-16	FDA Other approval	Rezvoglar	insulin glargine-aglr	Eli Lilly
2022-11-15	EU Authorisation	Enjaymo	sutimlimab	Recordati	orphan
2022-11-10	EU Authorisation	VidPrevtyn Beta	COVID-19 Vaccine	Sanofi
2022-11-10	EU Positive opinion	Pirfenidone Viatris	pirfenidone	Viatris	generic
2022-11-10	EU Positive opinion	VidPrevtyn Beta	COVID-19 Vaccine	Sanofi
2022-11-10	FDA New indication	Imfinzi	durvalumab	AstraZeneca
2022-11-10	FDA Other approval	Imjudo	tremelimumab-actl	AstraZeneca
2022-11-09	EU Authorisation	Teriflunomide Viatris (previously Teriflunomide Mylan)	teriflunomide	Viatris	generic
2022-11-09	EU Authorisation	Livtencity	maribavir	Takeda	orphan
2022-11-08	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron
2022-11-04	FDA New indication	Rybrevant	amivantamab-vmjw	J&J
2022-11-04	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2022-11-04	FDA Licence supplement	Rotarix	Rotavirus Vaccine, Live, Oral	GSK
2022-10-31	EU Authorisation	Beyfortus	nirsevimab	Sanofi	prime
2022-10-28	FDA New indication	Cotellic	cobimetinib	Roche	priority review
2022-10-25	FDA New medicine	Tecvayli	teclistamab-cqyv	J&J	priority review
2022-10-21	FDA New medicine	Imjudo	tremelimumab-actl	AstraZeneca	priority review
2022-10-21	FDA New indication	Rinvoq	upadacitinib	AbbVie
2022-10-21	FDA New indication	Imfinzi	durvalumab	AstraZeneca	priority review
2022-10-17	FDA New indication	Vemlidy	tenofovir alafenamide	Gilead	priority review
2022-10-14	FDA New indication	Turalio	pexidartinib	Daiichi Sankyo
2022-10-14	FDA New indication	Biktarvy	bictegravir + emtricitabine +1 more	Gilead
2022-10-14	FDA New indication	Lyumjev	insulin lispro-aabc	Eli Lilly
2022-10-14	FDA Licence supplement	Menveo	Meningococcal Oligosaccharide Diphtheria CRM197 Conjugate Vaccine	GSK
2022-10-13	EU Positive opinion	Dimethyl fumarate Teva	dimethyl	Teva	generic
2022-10-13	EU Positive opinion	Locametz	gozetotide	Novartis
2022-10-13	EU Positive opinion	Pluvicto	lutetium vipivotide tetraxetan	Novartis
2022-10-13	EU Positive opinion	Qdenga	dengue tetravalent vaccine	Takeda
2022-10-12	FDA New indication	Scemblix	asciminib	Novartis	priority review
2022-10-06	FDA New indication	Oxlumo	lumasiran	Alnylam
2022-10-06	FDA New indication	Turalio	pexidartinib	Daiichi Sankyo
2022-10-03	FDA New indication	Kisqali Femara Co-Pack (Copackaged)	letrozole + ribociclib	Novartis
2022-10-03	FDA New indication	Kisqali	ribociclib	Novartis
2022-10-03	FDA New indication	Aimovig	erenumab-aooe	Amgen
2022-09-28	FDA New indication	Dupixent	dupilumab	Regeneron	priority review
2022-09-27	FDA New indication	Vyxeos	cytarabine + daunorubicin	Jazz
2022-09-23	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2022-09-21	FDA New indication	Retevmo	selpercatinib	Eli Lilly
2022-09-21	FDA New indication	Retevmo	selpercatinib	Eli Lilly	priority review
2022-09-19	EU Authorisation	Tezspire	tezepelumab	AstraZeneca
2022-09-15	EU Authorisation	Amvuttra	vutrisiran	Alnylam	orphan
2022-09-15	EU Authorisation	Vabysmo	faricimab	Roche
2022-09-15	EU Authorisation	Mounjaro	tirzepatide	Eli Lilly
2022-09-15	EU Authorisation	Opdualag	relatlimab + nivolumab	BMS
2022-09-15	EU Authorisation	Lupkynis	voclosporin	Otsuka
2022-09-15	EU Positive opinion	Teriflunomide Viatris (previously Teriflunomide Mylan)	teriflunomide	Viatris	generic
2022-09-15	EU Positive opinion	Livtencity	maribavir	Takeda	orphan
2022-09-15	EU Positive opinion	Enjaymo	sutimlimab	Recordati	orphan
2022-09-15	EU Positive opinion	Beyfortus	nirsevimab	Sanofi	prime
2022-09-13	FDA New indication	Halaven	eribulin	Eisai	priority review
2022-09-09	FDA New indication	Xtandi	enzalutamide	Astellas
2022-09-09	FDA New indication	Xtandi	enzalutamide	Astellas
2022-09-02	FDA New indication	Orkambi	ivacaftor + lumacaftor	Vertex	priority review
2022-09-02	FDA New indication	Imfinzi	durvalumab	AstraZeneca	priority review
2022-09-01	FDA New medicine	Spevigo	spesolimab-sbzo	Boehringer Ingelheim	priority review
2022-09-01	FDA New indication	Kerendia	finerenone	Bayer
2022-08-31	FDA New medicine	Xenpozyme	olipudase alfa-rpcp	Sanofi	priority review
2022-08-31	FDA New indication	Alimta	pemetrexed	Eli Lilly
2022-08-26	FDA New indication	Pemazyre	pemigatinib	Incyte	priority review
2022-08-26	FDA New indication	Lynparza	olaparib	AstraZeneca	priority review
2022-08-25	EU Authorisation	Scemblix	asciminib	Novartis	orphan
2022-08-25	FDA Licence supplement	Comirnaty	COVID-19 Vaccine, mRNA	BioNTech
2022-08-24	EU Authorisation	Roctavian	valoctocogene roxaparvovec	BioMarin	advanced_therapyconditionalorphanprime
2022-08-24	FDA New indication	Imbruvica	ibrutinib	AbbVie	priority review
2022-08-24	FDA New indication	Imbruvica	ibrutinib	AbbVie	priority review
2022-08-24	FDA New indication	Imbruvica	ibrutinib	AbbVie	priority review
2022-08-24	FDA New indication	Imbruvica	ibrutinib	AbbVie	priority review
2022-08-24	FDA New indication	Imbruvica	ibrutinib	AbbVie	priority review
2022-08-24	FDA New indication	Imbruvica	ibrutinib	AbbVie
2022-08-24	FDA Other approval	Imbruvica	ibrutinib	AbbVie	priority review
2022-08-17	EU Authorisation	Sunlenca	lenacapavir	Gilead
2022-08-17	EU Authorisation	Rayvow	lasmiditan	Eli Lilly
2022-08-12	FDA New indication	Mirena	levonorgestrel	Bayer
2022-08-11	FDA New indication	Xofluza	baloxavir marboxil	Roche
2022-08-11	FDA New indication	Xofluza	baloxavir marboxil	Roche
2022-08-11	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2022-08-11	FDA Licence supplement	Rebinyn	Coagulation Factor IX, GlycoPEGylated	Novo Nordisk
2022-08-11	FDA Other approval	Xofluza	baloxavir marboxil	Roche
2022-08-10	EU Authorisation	Vyvgart	efgartigimod alfa	argenx	orphan
2022-08-10	FDA New indication	Tabrecta	capmatinib	Novartis	priority review
2022-08-05	FDA New indication	Nubeqa	darolutamide	Bayer	priority review
2022-08-05	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2022-08-03	FDA Other approval	Calquence	acalabrutinib	AstraZeneca
2022-08-03	FDA Other approval	Calquence	acalabrutinib	AstraZeneca
2022-07-29	FDA New indication	Abrilada	adalimumab-afzb	Pfizer
2022-07-28	FDA New indication	Cotellic	cobimetinib	Roche	priority review
2022-07-28	FDA New indication	Amjevita	adalimumab-atto	Amgen
2022-07-22	FDA New indication	Ultomiris	ravulizumab-cwvz	AstraZeneca
2022-07-21	EU Positive opinion	Amvuttra	vutrisiran	Alnylam	orphan
2022-07-21	EU Positive opinion	Vabysmo	faricimab	Roche
2022-07-21	EU Positive opinion	Mounjaro	tirzepatide	Eli Lilly
2022-07-21	EU Positive opinion	Tezspire	tezepelumab	AstraZeneca
2022-07-21	EU Positive opinion	Opdualag	relatlimab + nivolumab	BMS
2022-07-21	EU Positive opinion	Lupkynis	voclosporin	Otsuka
2022-07-18	FDA New indication	Opzelura	ruxolitinib	Incyte	priority review
2022-07-18	FDA New indication	Clolar	clofarabine	Sanofi
2022-07-15	FDA New indication	Bavencio	avelumab	Merck KGaA
2022-07-14	FDA New indication	Cabometyx	cabozantinib s-malate	Exelixis
2022-07-14	FDA New indication	Hulio	adalimumab-fkjp	Viatris
2022-07-14	FDA New indication	Opdivo	nivolumab	BMS
2022-07-07	FDA New indication	Krystexxa	pegloticase	Amgen	priority review
2022-07-01	FDA New indication	Tresiba	insulin degludec	Novo Nordisk
2022-06-30	FDA New indication	Kyprolis	carfilzomib	Amgen
2022-06-24	EU Authorisation	Nexviadyme	avalglucosidase alfa	Sanofi
2022-06-24	EU Authorisation	Xenpozyme	olipudase alfa	Sanofi	orphanprime
2022-06-23	EU Positive opinion	Vyvgart	efgartigimod alfa	argenx	orphan
2022-06-23	EU Positive opinion	Roctavian	valoctocogene roxaparvovec	BioMarin	advanced_therapyconditionalorphanprime
2022-06-23	EU Positive opinion	Sunlenca	lenacapavir	Gilead
2022-06-23	EU Positive opinion	Scemblix	asciminib	Novartis	orphan
2022-06-22	FDA New indication	Mekinist	trametinib dimethyl sulfoxide	Novartis	priority review
2022-06-22	FDA New indication	Tafinlar	dabrafenib	Novartis	priority review
2022-06-22	FDA Other approval	Pemetrexed Disodium	pemetrexed	Pfizer
2022-06-21	EU Authorisation	Filsuvez	birch bark extract	Chiesi	orphan
2022-06-20	EU Authorisation	Tabrecta	capmatinib	Novartis
2022-06-16	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie	priority review
2022-06-16	FDA Other approval	Skyrizi	risankizumab-rzaa	AbbVie	priority review
2022-06-13	FDA New medicine	Amvuttra	vutrisiran	Alnylam
2022-06-13	FDA New indication	Olumiant	baricitinib	Eli Lilly	priority review
2022-06-10	FDA Other approval	Pemetrexed Ditromethamine	pemetrexed ditromethamine	Pfizer
2022-06-07	FDA New indication	Dupixent	dupilumab	Regeneron	priority review
2022-06-06	FDA New indication	Cellcept	mycophenolate mofetil	Roche
2022-06-06	FDA New indication	Cellcept	mycophenolate mofetil	Roche
2022-06-06	FDA New indication	Cellcept	mycophenolate mofetil	Roche
2022-06-06	FDA New indication	Cellcept	mycophenolate mofetil	Roche
2022-06-06	FDA New indication	Cellcept	mycophenolate mofetil	Roche
2022-06-06	FDA New indication	Cellcept	mycophenolate mofetil	Roche
2022-06-06	FDA New indication	Cellcept	mycophenolate mofetil	Roche
2022-06-06	FDA New indication	Cellcept	mycophenolate mofetil	Roche
2022-06-03	FDA Vaccine / cell therapy	Priorix	Measles, Mumps and Rubella Vaccine Live	GSK
2022-06-03	EU Authorisation	Lunsumio	mosunetuzumab	Roche	conditionalorphan
2022-06-03	FDA New indication	Riabni	rituximab-arrx	Amgen
2022-05-27	FDA New indication	Evrysdi	risdiplam	Roche	priority review
2022-05-27	FDA New indication	Evrysdi	risdiplam	Roche
2022-05-27	FDA New indication	Mekinist	trametinib dimethyl sulfoxide	Novartis
2022-05-27	FDA New indication	Tafinlar	dabrafenib	Novartis
2022-05-27	FDA New indication	Beovu	brolucizumab-dbll	Novartis
2022-05-27	FDA New indication	Opdivo	nivolumab	BMS
2022-05-27	FDA New indication	Opdivo	nivolumab	BMS
2022-05-27	FDA New indication	Yervoy	ipilimumab	BMS
2022-05-25	EU Authorisation	Carvykti	ciltacabtagene autoleucel	J&J	advanced_therapyorphanprime
2022-05-25	FDA New indication	Tibsovo	ivosidenib	Servier	priority review
2022-05-20	FDA New indication	Vidaza	azacitidine	BMS	priority review
2022-05-20	FDA New indication	Dupixent	dupilumab	Regeneron	priority review
2022-05-20	FDA New indication	Keytruda	pembrolizumab	Merck
2022-05-19	EU Positive opinion	Xenpozyme	olipudase alfa	Sanofi	orphanprime
2022-05-13	FDA New medicine	Mounjaro, Mounjaro (Autoinjector)	tirzepatide	Eli Lilly	priority review
2022-05-13	EU Authorisation	Dimethyl fumarate Mylan	dimethyl	Viatris	generic
2022-05-11	FDA New indication	Opdivo	nivolumab	BMS
2022-05-11	FDA New indication	Yervoy	ipilimumab	BMS
2022-05-10	FDA New indication	Olumiant	baricitinib	Eli Lilly	priority review
2022-05-09	FDA New indication	Brilinta	ticagrelor	AstraZeneca	priority review
2022-05-04	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2022-05-04	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2022-05-04	FDA New indication	Taltz	ixekizumab	Eli Lilly
2022-05-02	FDA New indication	Emend	fosaprepitant dimeglumine	Merck
2022-05-02	FDA Other approval	Bortezomib	bortezomib	Pfizer
2022-04-29	FDA New indication	Rinvoq	upadacitinib	AbbVie
2022-04-29	FDA Other approval	Ermeza	levothyroxine	Viatris
2022-04-28	FDA New indication	Ninlaro	ixazomib	Takeda
2022-04-27	FDA New indication	Epclusa	sofosbuvir + velpatasvir	Gilead
2022-04-27	FDA New indication	Epclusa	sofosbuvir + velpatasvir	Gilead
2022-04-27	FDA New indication	Ultomiris	ravulizumab-cwvz	AstraZeneca	priority review
2022-04-25	EU Authorisation	Uplizna	inebilizumab	Amgen
2022-04-25	EU Authorisation	Vydura	rimegepant	Pfizer
2022-04-25	EU Authorisation	Truvelog Mix 30	insulin aspart	Sanofi	biosimilar
2022-04-25	FDA New indication	Veklury	remdesivir	Gilead	priority review
2022-04-22	EU Positive opinion	Lunsumio	mosunetuzumab	Roche	conditionalorphan
2022-04-22	EU Positive opinion	Filsuvez	birch bark extract	Chiesi	orphan
2022-04-22	EU Positive opinion	Tabrecta	capmatinib	Novartis
2022-04-18	FDA New indication	Lupron Depot	leuprolide	AbbVie
2022-04-18	FDA New indication	Lupron Depot	leuprolide	AbbVie
2022-04-13	EU Authorisation	Padcev	enfortumab vedotin	Astellas
2022-04-11	FDA New indication	Nurtec Odt	rimegepant	Pfizer
2022-04-11	FDA New indication	Xigduo Xr	dapagliflozin + metformin	AstraZeneca
2022-04-07	FDA New indication	Gilotrif	afatinib dimaleate	Boehringer Ingelheim	priority review
2022-04-05	FDA Other approval	Vijoice	alpelisib	Novartis	priority review
2022-04-04	EU Authorisation	Breyanzi	lisocabtagene maraleucel	BMS	advanced_therapyprime
2022-03-30	FDA New indication	Triumeq	abacavir + dolutegravir +1 more	GSK	priority review
2022-03-30	FDA Other approval	Triumeq Pd	abacavir + dolutegravir +1 more	GSK	priority review
2022-03-29	FDA New indication	Cabenuva Kit	cabotegravir + rilpivirine	GSK	priority review
2022-03-29	FDA New indication	Cabenuva Kit	cabotegravir + rilpivirine	GSK	priority review
2022-03-29	FDA New indication	Vocabria	cabotegravir	GSK	priority review
2022-03-29	FDA New indication	Vocabria	cabotegravir	GSK	priority review
2022-03-29	FDA New indication	Edurant	rilpivirine	J&J	priority review
2022-03-29	FDA New indication	Edurant	rilpivirine	J&J	priority review
2022-03-28	FDA New indication	Ozempic	semaglutide	Novo Nordisk
2022-03-25	EU Authorisation	Evusheld	tixagevimab + cilgavimab	AstraZeneca
2022-03-25	FDA New indication	Fintepla	fenfluramine	UCB	priority review
2022-03-24	EU Positive opinion	Evusheld	tixagevimab + cilgavimab	AstraZeneca
2022-03-24	EU Positive opinion	Carvykti	ciltacabtagene autoleucel	J&J	advanced_therapyorphanprime
2022-03-23	FDA New medicine	Pluvicto	lutetium lu-177 vipivotide tetraxetan	Novartis	priority review
2022-03-23	FDA New indication	Cabenuva Kit	cabotegravir + rilpivirine	GSK
2022-03-23	FDA New indication	Vocabria	cabotegravir	GSK
2022-03-23	FDA Other approval	Locametz	gallium ga-68 gozetotide	Novartis
2022-03-22	FDA New indication	Empliciti	elotuzumab	BMS
2022-03-21	FDA New indication	Keytruda	pembrolizumab	Merck
2022-03-18	FDA New medicine	Opdualag	nivolumab + relatlimab-rmbw	BMS	priority review
2022-03-16	FDA New indication	Rinvoq	upadacitinib	AbbVie	priority review
2022-03-11	FDA New indication	Lynparza	olaparib	AstraZeneca	priority review
2022-03-04	FDA New indication	Darzalex	daratumumab	J&J
2022-03-04	FDA New indication	Opdivo	nivolumab	BMS	priority review
2022-03-01	FDA New indication	Mayzent	siponimod	Novartis
2022-02-28	FDA Vaccine / cell therapy	Carvykti	ciltacabtagene autoleucel	J&J
2022-02-28	FDA New indication	Alunbrig	brigatinib	Takeda
2022-02-28	FDA New indication	Actemra	tocilizumab	Roche
2022-02-25	FDA Other approval	Acuvue Theravision With Ketotifen	ketotifen	J&J
2022-02-24	EU Positive opinion	Dimethyl fumarate Mylan	dimethyl	Viatris	generic
2022-02-24	EU Positive opinion	Vydura	rimegepant	Pfizer
2022-02-24	EU Positive opinion	Truvelog Mix 30	insulin aspart	Sanofi	biosimilar
2022-02-24	EU Positive opinion	Padcev	enfortumab vedotin	Astellas
2022-02-24	FDA New indication	Jardiance	empagliflozin	Boehringer Ingelheim	priority review
2022-02-16	EU Authorisation	Sitagliptin / Metformin hydrochloride Mylan	sitagliptin + metformin	Viatris	generic
2022-02-16	EU Authorisation	Tepmetko	tepotinib	Merck KGaA
2022-02-16	EU Authorisation	Kerendia	finerenone	Bayer
2022-02-15	FDA New indication	Iclusig	ponatinib	Takeda
2022-02-14	EU Authorisation	Ngenla	somatrogon	Pfizer	orphan
2022-02-14	EU Authorisation	Prevenar 20 (previously Apexxnar)	pneumococcal polysaccharide conjugate vaccine	Pfizer
2022-02-14	EU Authorisation	Saphnelo	anifrolumab	AstraZeneca
2022-02-14	EU Authorisation	Oxbryta	voxelotor	Pfizer	orphanprime
2022-02-14	FDA New indication	Gazyva	obinutuzumab	Roche
2022-02-07	FDA New indication	Cabenuva Kit	cabotegravir + rilpivirine	GSK
2022-02-07	FDA New indication	Vocabria	cabotegravir	GSK
2022-02-04	FDA New medicine	Enjaymo	sutimlimab-jome	Recordati	priority review
2022-02-04	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2022-02-03	FDA New indication	Xigduo Xr	dapagliflozin + metformin	AstraZeneca
2022-01-31	FDA New indication	Cabenuva Kit	cabotegravir + rilpivirine	GSK
2022-01-31	FDA New indication	Vocabria	cabotegravir	GSK
2022-01-31	FDA New indication	Lynparza	olaparib	AstraZeneca
2022-01-31	FDA New indication	Edurant	rilpivirine	J&J
2022-01-28	FDA New medicine	Vabysmo	faricimab-svoa	Roche	priority review
2022-01-28	EU Authorisation	Paxlovid	nirmatrelvir + ritonavir	Pfizer
2022-01-28	FDA New indication	Mekinist	trametinib dimethyl sulfoxide	Novartis
2022-01-28	FDA New indication	Tafinlar	dabrafenib	Novartis
2022-01-28	FDA New indication	Geodon	ziprasidone	Viatris
2022-01-27	EU Positive opinion	Paxlovid	nirmatrelvir + ritonavir	Pfizer
2022-01-27	EU Positive opinion	Breyanzi	lisocabtagene maraleucel	BMS	advanced_therapyprime
2022-01-27	FDA New indication	Delstrigo	doravirine + lamivudine +1 more	Merck	priority review
2022-01-27	FDA New indication	Pifeltro	doravirine	Merck	priority review
2022-01-25	FDA Licence supplement	Quadracel	Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine	Sanofi
2022-01-24	EU Authorisation	Vyepti	eptinezumab	Lundbeck
2022-01-24	FDA New indication	Rukobia	fostemsavir	GSK
2022-01-21	FDA New indication	Veklury	remdesivir	Gilead	priority review
2022-01-21	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2022-01-20	FDA New indication	Dovato	dolutegravir + lamivudine	GSK
2022-01-20	FDA New indication	Dovato	dolutegravir + lamivudine	GSK
2022-01-14	FDA New medicine	Cibinqo	abrocitinib	Pfizer	priority review
2022-01-14	FDA New indication	Rinvoq	upadacitinib	AbbVie	priority review
2022-01-13	FDA New indication	Topamax, Topamax Sprinkle	topiramate	J&J
2022-01-13	FDA New indication	Topamax	topiramate	J&J
2022-01-07	FDA New indication	Descovy	emtricitabine + tenofovir alafenamide	Gilead	priority review
2022-01-07	FDA New indication	Genvoya	cobicistat + elvitegravir +2 more	Gilead	priority review
2022-01-06	EU Authorisation	Lumykras	sotorasib	Amgen	conditional
2022-01-06	EU Authorisation	Wegovy	semaglutide	Novo Nordisk
2022-01-06	EU Authorisation	Riltrava Aerosphere	formoterol + glycopyrronium +1 more	AstraZeneca
2021-12-30	FDA New indication	Afinitor	everolimus	Novartis
2021-12-27	FDA New indication	Rexulti	brexpiprazole	Otsuka	priority review
2021-12-22	FDA New medicine	Leqvio	inclisiran	Novartis
2021-12-22	FDA New indication	Cosentyx	secukinumab	Novartis	priority review
2021-12-22	FDA New indication	Cosentyx	secukinumab	Novartis	priority review
2021-12-20	EU Authorisation	Nuvaxovid	COVID-19 Vaccine	Sanofi
2021-12-20	EU Positive opinion	Nuvaxovid	COVID-19 Vaccine	Sanofi
2021-12-20	FDA New indication	Vocabria	cabotegravir	GSK	priority review
2021-12-20	FDA New indication	Otezla	apremilast	Amgen
2021-12-20	FDA Other approval	Xarelto	rivaroxaban	J&J	priority review
2021-12-20	FDA Other approval	Apretude	cabotegravir	GSK	priority review
2021-12-19	FDA New indication	Lenvima	lenvatinib	Eisai
2021-12-17	FDA New medicine	Tezspire	tezepelumab-ekko	AstraZeneca	priority review
2021-12-17	FDA New medicine	Vyvgart	efgartigimod alfa	argenx
2021-12-17	EU Authorisation	Xevudy	sotrovimab	GSK
2021-12-17	FDA New indication	Keytruda	pembrolizumab	Merck
2021-12-17	FDA Other approval	Rezvoglar	insulin glargine-aglr	Eli Lilly
2021-12-16	EU Positive opinion	Sitagliptin / Metformin hydrochloride Mylan	sitagliptin + metformin	Viatris	generic
2021-12-16	EU Positive opinion	Xevudy	sotrovimab	GSK
2021-12-16	EU Positive opinion	Ngenla	somatrogon	Pfizer	orphan
2021-12-16	EU Positive opinion	Tepmetko	tepotinib	Merck KGaA
2021-12-16	EU Positive opinion	Prevenar 20 (previously Apexxnar)	pneumococcal polysaccharide conjugate vaccine	Pfizer
2021-12-16	EU Positive opinion	Rayvow	lasmiditan	Eli Lilly
2021-12-16	EU Positive opinion	Kerendia	finerenone	Bayer
2021-12-16	EU Positive opinion	Saphnelo	anifrolumab	AstraZeneca
2021-12-16	EU Positive opinion	Oxbryta	voxelotor	Pfizer	orphanprime
2021-12-16	FDA Licence supplement	Comirnaty	COVID-19 Vaccine, mRNA	BioNTech
2021-12-15	FDA New indication	Orencia	abatacept	BMS	priority review
2021-12-14	FDA New indication	Rinvoq	upadacitinib	AbbVie
2021-12-14	FDA New indication	Xeljanz Xr	tofacitinib	Pfizer
2021-12-13	EU Authorisation	Vaxneuvance	pneumococcal polysaccharide conjugate vaccine	Merck
2021-12-10	FDA New indication	Kisqali Femara Co-Pack (Copackaged)	letrozole + ribociclib	Novartis
2021-12-10	FDA New indication	Kisqali	ribociclib	Novartis
2021-12-10	FDA New indication	Lastacaft	alcaftadine	AbbVie
2021-12-10	FDA New indication	Epzicom	abacavir + lamivudine	GSK
2021-12-09	EU Authorisation	Cibinqo	abrocitinib	Pfizer
2021-12-09	FDA New indication	Zepatier	elbasvir + grazoprevir	Merck
2021-12-03	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-12-02	FDA New indication	Rituxan	rituximab	Roche	priority review
2021-11-30	FDA New indication	Kyprolis	carfilzomib	Amgen
2021-11-30	FDA New indication	Darzalex Faspro	daratumumab and hyaluronidase-fihj	J&J
2021-11-23	FDA New medicine	Livtencity	maribavir	Takeda	priority review
2021-11-22	EU Authorisation	Trodelvy	sacituzumab govitecan	Gilead
2021-11-19	FDA New medicine	Voxzogo	vosoritide	BioMarin
2021-11-19	FDA New indication	Kanuma	sebelipase alfa	AstraZeneca
2021-11-17	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-11-15	EU Authorisation	Vumerity	diroximel	Biogen
2021-11-15	EU Authorisation	Sugammadex Mylan	sugammadex	Viatris	generic
2021-11-15	FDA New indication	Ruxience	rituximab-pvvr	Pfizer
2021-11-15	FDA New indication	Mvasi	bevacizumab-awwb	Amgen
2021-11-15	EU Refusal	Raylumis	tanezumab	Pfizer
2021-11-12	EU Authorisation	Ronapreve	casirivimab + imdevimab	Roche
2021-11-12	EU Authorisation	Rivaroxaban Viatris (previously Rivaroxaban Mylan)	rivaroxaban	Viatris	generic
2021-11-11	EU Positive opinion	Uplizna	inebilizumab	Amgen
2021-11-11	EU Positive opinion	Ronapreve	casirivimab + imdevimab	Roche
2021-11-11	EU Positive opinion	Lumykras	sotorasib	Amgen	conditional
2021-11-11	EU Positive opinion	Nexviadyme	avalglucosidase alfa	Sanofi
2021-11-11	EU Positive opinion	Wegovy	semaglutide	Novo Nordisk
2021-11-11	EU Positive opinion	Riltrava Aerosphere	formoterol + glycopyrronium +1 more	AstraZeneca
2021-11-11	EU Positive opinion	Vyepti	eptinezumab	Lundbeck
2021-11-04	FDA New indication	Byetta	exenatide synthetic	AstraZeneca
2021-10-29	FDA New medicine	Scemblix	asciminib	Novartis	priority review
2021-10-29	FDA New medicine	Scemblix	asciminib	Novartis	priority review
2021-10-28	FDA Other approval	Vuity	pilocarpine	AbbVie
2021-10-22	FDA Other approval	Susvimo	ranibizumab	Roche	priority review
2021-10-20	FDA New indication	Dupixent	dupilumab	Regeneron
2021-10-15	FDA New indication	Cyltezo	adalimumab-adbm	Boehringer Ingelheim
2021-10-15	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2021-10-14	EU Positive opinion	Vaxneuvance	pneumococcal polysaccharide conjugate vaccine	Merck
2021-10-14	EU Positive opinion	Cibinqo	abrocitinib	Pfizer
2021-10-14	FDA New indication	Vimpat	lacosamide	UCB
2021-10-14	FDA New indication	Vimpat	lacosamide	UCB
2021-10-14	FDA New indication	Vimpat	lacosamide	UCB
2021-10-13	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-10-13	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-10-12	FDA New indication	Verzenio	abemaciclib	Eli Lilly
2021-10-12	FDA New indication	Verzenio	abemaciclib	Eli Lilly
2021-10-12	FDA New indication	Verzenio	abemaciclib	Eli Lilly
2021-10-07	FDA New indication	Biktarvy	bictegravir + emtricitabine +1 more	Gilead	priority review
2021-10-06	FDA New indication	Tecentriq	atezolizumab	Roche
2021-10-04	FDA New indication	Venclexta	venetoclax	AbbVie
2021-09-28	FDA New medicine	Qulipta	atogepant	AbbVie	priority review
2021-09-24	FDA New indication	Repatha	evolocumab	Amgen
2021-09-23	FDA New indication	Tasigna	nilotinib	Novartis	priority review
2021-09-23	FDA New indication	Tasigna	nilotinib	Novartis	priority review
2021-09-22	FDA New indication	Jakafi	ruxolitinib	Incyte	priority review
2021-09-21	FDA Other approval	Opzelura	ruxolitinib	Incyte	priority review
2021-09-20	FDA New medicine	Tivdak	tisotumab vedotin-tftv	Pfizer	priority review
2021-09-17	FDA New indication	Segluromet	ertugliflozin + metformin	Merck
2021-09-17	FDA New indication	Steglujan	ertugliflozin + sitagliptin	Merck
2021-09-17	FDA New indication	Steglatro	ertugliflozin	Merck
2021-09-17	FDA New indication	Cabometyx	cabozantinib s-malate	Exelixis	priority review
2021-09-16	EU Positive opinion	Rivaroxaban Viatris (previously Rivaroxaban Mylan)	rivaroxaban	Viatris	generic
2021-09-16	EU Positive opinion	Vumerity	diroximel	Biogen
2021-09-16	EU Positive opinion	Sugammadex Mylan	sugammadex	Viatris	generic
2021-09-16	EU Positive opinion	Trodelvy	sacituzumab govitecan	Gilead
2021-09-15	FDA New medicine	Exkivity	mobocertinib	Takeda	priority review
2021-09-09	FDA New indication	Talzenna	talazoparib	Pfizer
2021-09-07	FDA New indication	Erleada	apalutamide	J&J
2021-08-31	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-08-31	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-08-30	FDA New indication	Invega Hafyera, Invega Trinza	paliperidone	J&J
2021-08-27	FDA New indication	Briviact	brivaracetam	UCB
2021-08-27	FDA New indication	Briviact	brivaracetam	UCB
2021-08-27	FDA New indication	Briviact	brivaracetam	UCB
2021-08-26	EU Authorisation	Voxzogo	vosoritide	BioMarin	orphan
2021-08-26	EU Authorisation	Minjuvi	tafasitamab	Incyte	conditionalorphan
2021-08-25	FDA New indication	Tibsovo	ivosidenib	Servier	priority review
2021-08-23	FDA Vaccine / cell therapy	Comirnaty	COVID-19 Vaccine, mRNA	BioNTech
2021-08-23	FDA New indication	Xarelto	rivaroxaban	J&J
2021-08-20	EU Authorisation	Abiraterone Mylan	abiraterone	Viatris	generic
2021-08-20	EU Authorisation	Bimzelx	bimekizumab	UCB
2021-08-19	FDA New indication	Opdivo	nivolumab	BMS	priority review
2021-08-18	EU Authorisation	Fingolimod Mylan	fingolimod	Viatris	generic
2021-08-18	EU Authorisation	Fingolimod Mylan	fingolimod	Viatris	generic
2021-08-18	EU Authorisation	Evrenzo	roxadustat	Astellas
2021-08-18	EU Authorisation	Abecma	idecabtagene vicleucel	BMS	advanced_therapyorphanprime
2021-08-18	FDA New indication	Jardiance	empagliflozin	Boehringer Ingelheim
2021-08-17	FDA Other approval	Jemperli	dostarlimab-gxly	GSK	priority review
2021-08-13	FDA New medicine	Welireg	belzutifan	Merck	priority review
2021-08-13	FDA Vaccine / cell therapy	Ticovac	Tick-Borne Encephalitis Vaccine	Pfizer
2021-08-13	FDA New indication	Lyumjev	insulin lispro-aabc	Eli Lilly
2021-08-12	FDA New indication	Xywav	calcium oxybate + magnesium oxybate +2 more	Jazz	priority review
2021-08-11	FDA New indication	Mirena	levonorgestrel	Bayer
2021-08-10	FDA New indication	Lenvima	lenvatinib	Eisai	priority review
2021-08-10	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-08-06	FDA New medicine	Nexviazyme	avalglucosidase alfa-ngpt	Sanofi	priority review
2021-07-30	FDA New medicine	Saphnelo	anifrolumab-fnia	AstraZeneca
2021-07-30	FDA New indication	Istodax	romidepsin	BMS
2021-07-30	FDA New indication	Adlyxin	lixisenatide	Sanofi
2021-07-30	FDA Other approval	Micafungin	micafungin	Teva
2021-07-29	FDA New indication	Vyvanse	lisdexamfetamine dimesylate	Takeda	priority review
2021-07-29	FDA New indication	Vyvanse	lisdexamfetamine dimesylate	Takeda	priority review
2021-07-29	FDA New indication	Nucala	mepolizumab	GSK
2021-07-29	FDA New indication	Nucala	mepolizumab	GSK
2021-07-29	FDA Other approval	Uptravi	selexipag	J&J
2021-07-28	FDA New indication	Botox, Botox Cosmetic	OnabotulinumtoxinA	AbbVie
2021-07-28	FDA Other approval	Semglee	insulin glargine-yfgn	Viatris
2021-07-26	FDA New indication	Keytruda	pembrolizumab	Merck
2021-07-26	FDA New indication	Keytruda	pembrolizumab	Merck
2021-07-23	FDA Licence supplement	Shingrix	Zoster Vaccine Recombinant, Adjuvanted	GSK
2021-07-22	FDA New indication	Bydureon Bcise	exenatide synthetic	AstraZeneca	priority review
2021-07-22	FDA New indication	Bydureon, Bydureon Pen	exenatide synthetic	AstraZeneca	priority review
2021-07-22	FDA New indication	Dalvance	dalbavancin	AbbVie
2021-07-21	FDA New indication	Lenvima	lenvatinib	Eisai	priority review
2021-07-21	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-07-20	FDA New medicine	Bylvay	odevixibat	Ipsen	priority review
2021-07-16	FDA New medicine	Fexinidazole	fexinidazole	Sanofi	priority review
2021-07-16	FDA Vaccine / cell therapy	Vaxneuvance	Pneumococcal 15-valent Conjugate Vaccine	Merck
2021-07-16	EU Authorisation	Verquvo	vericiguat	Bayer
2021-07-16	EU Authorisation	Bylvay	odevixibat	Ipsen	acceleratedexceptionalorphanprime
2021-07-16	FDA New indication	Prograf	tacrolimus	Astellas	priority review
2021-07-16	FDA New indication	Prograf	tacrolimus	Astellas	priority review
2021-07-16	FDA New indication	Prograf	tacrolimus	Astellas	priority review
2021-07-15	FDA New indication	Opdivo	nivolumab	BMS
2021-07-09	FDA New medicine	Kerendia	finerenone	Bayer	priority review
2021-07-09	FDA New indication	Tivicay Pd	dolutegravir	GSK
2021-07-09	FDA New indication	Juluca	dolutegravir + rilpivirine	GSK
2021-07-09	FDA New indication	Airduo Digihaler, Airduo Respiclick	fluticasone + salmeterol xinafoate	Teva
2021-07-09	FDA New indication	Armonair Digihaler, Armonair Respiclick	fluticasone	Teva	priority review
2021-07-09	FDA New indication	Tivicay	dolutegravir	GSK
2021-07-09	FDA New indication	Darzalex Faspro	daratumumab and hyaluronidase-fihj	J&J
2021-07-09	FDA New indication	Padcev	enfortumab vedotin-ejfv	Astellas	priority review
2021-07-09	FDA New indication	Padcev	enfortumab vedotin-ejfv	Astellas	priority review
2021-07-01	FDA New indication	Keytruda	pembrolizumab	Merck
2021-06-30	FDA New medicine	Rylaze	asparaginase erwinia chrysanthemi-rywn	Jazz
2021-06-25	FDA New indication	Bridion	sugammadex	Merck
2021-06-24	EU Authorisation	Enspryng	satralizumab	Roche	orphan
2021-06-24	EU Positive opinion	Voxzogo	vosoritide	BioMarin	orphan
2021-06-24	EU Positive opinion	Minjuvi	tafasitamab	Incyte	conditionalorphan
2021-06-24	EU Positive opinion	Abiraterone Mylan	abiraterone	Viatris	generic
2021-06-24	EU Positive opinion	Bimzelx	bimekizumab	UCB
2021-06-24	EU Positive opinion	Evrenzo	roxadustat	Astellas
2021-06-24	EU Positive opinion	Abecma	idecabtagene vicleucel	BMS	advanced_therapyorphanprime
2021-06-24	FDA New indication	Austedo	deutetrabenazine	Teva	priority review
2021-06-21	FDA New indication	Pradaxa	dabigatran etexilate	Boehringer Ingelheim	priority review
2021-06-21	FDA Other approval	Pradaxa	dabigatran etexilate	Boehringer Ingelheim	priority review
2021-06-21	FDA Other approval	Daptomycin	daptomycin	Pfizer
2021-06-17	EU Authorisation	Koselugo	selumetinib	AstraZeneca	conditionalorphan
2021-06-17	EU Authorisation	Onureg	azacitidine	BMS
2021-06-17	FDA New indication	Noxafil	posaconazole	Merck
2021-06-17	FDA New indication	Noxafil	posaconazole	Merck
2021-06-17	FDA New indication	Toviaz	fesoterodine	Pfizer	priority review
2021-06-17	FDA Other approval	Astepro Allergy, Children'S Astepro Allergy	azelastine	Bayer
2021-06-14	FDA New indication	Dupixent	dupilumab	Regeneron
2021-06-10	FDA New indication	Mavyret	glecaprevir + pibrentasvir	AbbVie	priority review
2021-06-10	FDA New indication	Epclusa	sofosbuvir + velpatasvir	Gilead	priority review
2021-06-10	FDA Other approval	Mavyret	glecaprevir + pibrentasvir	AbbVie	priority review
2021-06-10	FDA Other approval	Epclusa	sofosbuvir + velpatasvir	Gilead	priority review
2021-06-08	FDA Vaccine / cell therapy	Prevnar 20	Pneumococcal 20-valent Conjugate Vaccine	Pfizer
2021-06-08	FDA New indication	Trikafta (Copackaged)	elexacaftor, ivacaftor, tezacaftor + ivacaftor	Vertex	priority review
2021-06-07	FDA New medicine	Aduhelm	aducanumab-avwa	Biogen	priority review
2021-06-07	FDA New indication	Ultomiris	ravulizumab-cwvz	AstraZeneca	priority review
2021-06-04	FDA Other approval	Wegovy, Wegovy Flextouch	semaglutide	Novo Nordisk	priority review
2021-06-01	FDA New medicine	Brexafemme	ibrexafungerp	GSK	priority review
2021-05-31	FDA New indication	Noxafil	posaconazole	Merck
2021-05-31	FDA New indication	Noxafil	posaconazole	Merck
2021-05-31	FDA Other approval	Noxafil Powdermix Kit	posaconazole	Merck
2021-05-28	FDA New medicine	Lumakras	sotorasib	Amgen	priority review
2021-05-28	FDA New indication	Cosentyx	secukinumab	Novartis
2021-05-27	FDA New indication	Nurtec Odt	rimegepant	Pfizer
2021-05-25	FDA New indication	Yervoy	ipilimumab	BMS
2021-05-21	FDA New medicine	Rybrevant	amivantamab-vmjw	J&J	priority review
2021-05-20	EU Positive opinion	Verquvo	vericiguat	Bayer
2021-05-20	EU Positive opinion	Bylvay	odevixibat	Ipsen	acceleratedexceptionalorphanprime
2021-05-20	FDA New indication	Opdivo	nivolumab	BMS	priority review
2021-05-05	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-04-30	FDA New indication	Ferriprox	deferiprone	Chiesi
2021-04-30	FDA New indication	Ferriprox	deferiprone	Chiesi
2021-04-30	FDA New indication	Aubagio	teriflunomide	Sanofi
2021-04-30	FDA New indication	Farxiga	dapagliflozin	AstraZeneca	priority review
2021-04-30	FDA New indication	Ferriprox	deferiprone	Chiesi
2021-04-29	FDA New indication	Morphine Sulfate	morphine	Pfizer
2021-04-26	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2021-04-26	FDA New indication	Skyrizi	risankizumab-rzaa	AbbVie
2021-04-23	FDA New indication	Ingrezza	valbenazine	Neurocrine Biosciences
2021-04-22	FDA New medicine	Jemperli	dostarlimab-gxly	GSK	priority review
2021-04-22	EU Positive opinion	Koselugo	selumetinib	AstraZeneca	conditionalorphan
2021-04-22	EU Positive opinion	Enspryng	satralizumab	Roche	orphan
2021-04-22	EU Positive opinion	Onureg	azacitidine	BMS
2021-04-21	EU Authorisation	Jemperli	dostarlimab	GSK
2021-04-19	FDA New indication	Diovan	valsartan	Novartis
2021-04-16	FDA New indication	Opdivo	nivolumab	BMS	priority review
2021-04-13	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2021-04-09	FDA New indication	Xolair	omalizumab	Roche
2021-04-01	FDA New indication	Praluent	alirocumab	Regeneron
2021-03-31	EU Authorisation	Sogroya	somapacitan	Novo Nordisk	orphan
2021-03-31	FDA New indication	Sarclisa	isatuximab-irfc	Sanofi
2021-03-30	FDA New indication	Vyxeos	cytarabine + daunorubicin	Jazz	priority review
2021-03-29	FDA New indication	Methotrexate Lpf, Methotrexate Preservative Free	methotrexate	Pfizer
2021-03-26	EU Authorisation	BroPair Spiromax	salmeterol + fluticasone	Teva
2021-03-26	EU Authorisation	Kesimpta	ofatumumab	Novartis
2021-03-26	EU Authorisation	Vazkepa	icosapent ethyl	Recordati
2021-03-26	EU Authorisation	Pemazyre	pemigatinib	Incyte	conditionalorphan
2021-03-26	EU Authorisation	Evrysdi	risdiplam	Roche	acceleratedprime
2021-03-26	EU Authorisation	Seffalair Spiromax	salmeterol + fluticasone	Teva
2021-03-25	FDA New indication	Vitrakvi	larotrectinib	Bayer
2021-03-25	FDA New indication	Vitrakvi	larotrectinib	Bayer
2021-03-22	FDA New medicine	Zegalogue, Zegalogue (Autoinjector)	dasiglucagon	Zealand
2021-03-22	FDA New indication	Keytruda	pembrolizumab	Merck	priority review
2021-03-16	FDA New indication	Keytruda	pembrolizumab	Merck
2021-03-16	FDA New indication	Keytruda	pembrolizumab	Merck
2021-03-11	EU Authorisation	Jcovden (previously COVID-19 Vaccine Janssen)	COVID-19 vaccine	J&J
2021-03-11	EU Positive opinion	Jcovden (previously COVID-19 Vaccine Janssen)	COVID-19 vaccine	J&J
2021-03-11	FDA New indication	Lynparza	olaparib	AstraZeneca
2021-03-11	FDA New indication	Blincyto	blinatumomab	Amgen	priority review
2021-03-11	FDA New indication	Blincyto	blinatumomab	Amgen	priority review
2021-03-11	FDA New indication	Fabrazyme	agalsidase beta	Sanofi
2021-03-04	FDA New indication	Actemra	tocilizumab	Roche	priority review
2021-03-03	FDA Vaccine / cell therapy	Abecma	idecabtagene vicleucel	BMS
2021-03-03	FDA New indication	Lorbrena	lorlatinib	Pfizer	priority review
2021-03-01	FDA New indication	Dovato	dolutegravir + lamivudine	GSK
2021-03-01	FDA New indication	Triumeq	abacavir + dolutegravir +1 more	GSK
2021-02-26	FDA Other approval	Repatha	evolocumab	Amgen
2021-02-25	FDA New medicine	Amondys 45	casimersen	Sarepta	priority review
2021-02-25	EU Positive opinion	Lextemy	bevacizumab	Viatris	biosimilar
2021-02-25	EU Positive opinion	Jemperli	dostarlimab	GSK
2021-02-25	EU Positive opinion	Evrysdi	risdiplam	Roche	acceleratedprime
2021-02-24	FDA New indication	Biktarvy	bictegravir + emtricitabine +1 more	Gilead
2021-02-24	FDA New indication	Humira	adalimumab	AbbVie
2021-02-22	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron	priority review
2021-02-19	FDA New indication	Imfinzi	durvalumab	AstraZeneca	priority review
2021-02-17	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2021-02-17	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2021-02-17	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2021-02-17	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2021-02-17	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2021-02-17	FDA New indication	Tecentriq	atezolizumab	Roche	priority review
2021-02-16	FDA New indication	Entresto	sacubitril + valsartan	Novartis
2021-02-11	FDA New medicine	Evkeeza	evinacumab-dgnb	Regeneron	priority review
2021-02-11	EU Authorisation	Retsevmo	selpercatinib	Eli Lilly
2021-02-11	EU Authorisation	Tukysa	tucatinib	Pfizer
2021-02-09	FDA New indication	Zirabev	bevacizumab-bvzr	Pfizer
2021-02-09	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron	priority review
2021-02-09	FDA New indication	Libtayo	cemiplimab-rwlc	Regeneron	priority review
2021-02-09	FDA New indication	Botox, Botox Cosmetic	OnabotulinumtoxinA	AbbVie
2021-02-08	EU Authorisation	Lumoxiti	moxetumomab pasudotox	AstraZeneca
2021-02-08	EU Authorisation	Inrebic	fedratinib	BMS	orphan
2021-02-05	FDA New indication	Biktarvy	bictegravir + emtricitabine +1 more	Gilead
2021-02-04	EU Authorisation	Rukobia	fostemsavir	GSK
2021-02-03	FDA New medicine	Tepmetko	tepotinib	Merck KGaA	priority review
2021-02-01	FDA New indication	Orilissa	elagolix	AbbVie
2021-02-01	FDA New indication	Orilissa	elagolix	AbbVie
2021-02-01	FDA New indication	Orilissa	elagolix	AbbVie
2021-02-01	FDA New indication	Simponi Aria	golimumab	J&J
2021-01-30	FDA New indication	Uptravi	selexipag	J&J
2021-01-29	EU Authorisation	Vaxzevria (previously COVID-19 Vaccine AstraZeneca)	COVID-19 Vaccine	AstraZeneca
2021-01-29	EU Positive opinion	Vaxzevria (previously COVID-19 Vaccine AstraZeneca)	COVID-19 Vaccine	AstraZeneca
2021-01-29	FDA New indication	Plegridy	peginterferon beta-1a	Biogen
2021-01-28	EU Positive opinion	BroPair Spiromax	salmeterol + fluticasone	Teva
2021-01-28	EU Positive opinion	Vazkepa	icosapent ethyl	Recordati
2021-01-28	EU Positive opinion	Pemazyre	pemigatinib	Incyte	conditionalorphan
2021-01-28	FDA New indication	Nplate	romiplostim	Amgen	priority review
2021-01-22	FDA New indication	Cabometyx	cabozantinib s-malate	Exelixis	priority review
2021-01-22	FDA New indication	Trintellix	vortioxetine	Takeda	priority review
2021-01-22	FDA New indication	Carbaglu	carglumic acid	Recordati	priority review
2021-01-22	FDA New indication	Carbaglu	carglumic acid	Recordati	priority review
2021-01-22	FDA New indication	Bridion	sugammadex	Merck
2021-01-22	FDA New indication	Opdivo	nivolumab	BMS	priority review
2021-01-21	FDA New medicine	Cabenuva Kit	cabotegravir + rilpivirine	GSK	priority review
2021-01-21	FDA New indication	Edurant	rilpivirine	J&J	priority review
2021-01-21	FDA Other approval	Vocabria	cabotegravir	GSK	priority review
2021-01-19	FDA New medicine	Verquvo	vericiguat	Merck	priority review
2021-01-18	EU Authorisation	Enhertu	trastuzumab deruxtecan	Daiichi Sankyo	conditional
2021-01-15	FDA New indication	Darzalex Faspro	daratumumab and hyaluronidase-fihj	J&J	priority review
2021-01-15	FDA New indication	Enhertu	fam-trastuzumab deruxtecan-nxki	Daiichi Sankyo	priority review
2021-01-11	FDA New indication	Darzalex Faspro	daratumumab and hyaluronidase-fihj	J&J
2021-01-07	EU Authorisation	Xofluza	baloxavir marboxil	Roche
2021-01-07	FDA New indication	Nubeqa	darolutamide	Bayer	priority review
2021-01-06	EU Authorisation	Spikevax (previously COVID-19 Vaccine Moderna)	COVID-19 mRNA vaccine	Moderna
2021-01-04	EU Positive opinion	Spikevax (previously COVID-19 Vaccine Moderna)	COVID-19 mRNA vaccine	Moderna

Showing decisions since 2021-01-01. Earlier ones are held back to keep the table readable, not because they are missing.

Pivotal trials that just changed state #

A Phase 3 trial ending is the moment an answer exists, and it is on the public record before anyone announces what the answer was. Each row is a registry status change in the last 365 days across 17 of the largest drug companies, grouped by drug rather than by trial, newest first. Click any column header to sort.

Phase 3 trials that completed, terminated or posted results at large pharmaceutical companies
Changed	What happened	Company	Drug	Trial	Condition	Primary completion
2026-09-02	Trial completed	Sanofi	Fitusiran	ATLAS-PEDS	Hemophilia	2026-08-04
2026-08-27	Trial completed	Merck	pembrolizumab/vibostolimab	KEYVIBE-006	Carcinoma, Non-Small-Cell Lung	2026-06-15
2026-08-26	Trial completed	Novartis	TQJ230	Lp(a)HORIZON	Cardiovascular Disease and Lipoprotein(a)	2026-07-16
2026-08-21	Trial completed	BMS	Ipilimumab, Nivolumab	CheckMate 9DW	Hepatocellular Carcinoma	2026-07-09
2026-08-19	Trial completed	Eli Lilly	Lebrikizumab	ADtouch	Atopic Hand and Foot Dermatitis	2026-05-13
2026-08-17	Trial completed	Roche	Alectinib, Carboplatin, Cisplatin, Pemetrexed	HORIZON 2	Non-Small Cell Lung Cancer	2026-07-31
2026-08-14	Trial terminated	Gilead	F/TAF, F/TDF	DISCOVER	Pre-Exposure Prophylaxis of HIV-1 Infection	2019-01-31
2026-08-13	Trial completed	AbbVie	not stated on an experimental arm	NCT05995340	Atrophic Acne Scars	2026-07-14
2026-08-13	Trial completed	AbbVie	Adalimumab, Upadacitinib	SELECT- SWITCH	Rheumatoid Arthritis	2026-07-15
2026-08-12	Trial completed	Novo Nordisk	Oral semaglutide	NCT07271251	Type 2 Diabetes	2026-06-29
2026-08-12	Trial completed	AstraZeneca	Benralizumab	STEP	Severe Eosinophilic Asthma	2026-05-13
2026-08-11	Trial withdrawn	Sanofi	Itepekimab (SAR440340)	CEREN-4	Chronic Rhinosinusitis With Nasal Polyps	2027-10-20 (est.)
2026-07-30	Trial completed	J&J	Guselkumab	SOLSTICE	Arthritis, Psoriatic	2024-10-28
2026-07-30	Trial completed	J&J	Guselkumab, Ustekinumab	PSUMMIT-Jr	Arthritis, Juvenile	2026-01-12
2026-07-30	Trial completed	BMS	Cabozantinib, Ipilimumab, Nivolumab	CheckMate 9ER	Renal Cell Carcinoma	2020-02-12
2026-07-30	Trial completed	BMS	Xanomeline and Trospium Chloride Capsules	NCT05304767	Schizophrenia	2026-03-25
2026-07-29	Trial completed	Novartis	not stated on an experimental arm	NCT04179175	Hidradenitis Suppurativa	2023-05-26
2026-07-28	Trial completed	Takeda	TAK-279	NCT06323356	Erythrodermic Psoriasis, Generalized Pustular Psoriasis	2025-10-17
2026-07-28	Trial completed	Eli Lilly	Retatrutide	TRIUMPH-3, TRIUMPH-2 2 trials	Cardiovascular Diseases, Obesity, Obstructive Sleep Apnea	2026-04-16, 2026-06-16
2026-07-27	Trial completed	Novo Nordisk	Ziltivekimab B, Ziltivekimab C	ZEUS	Cardiovascular Risk, Chronic Kidney Disease, Inflammation	2026-06-09
2026-07-24	Trial terminated	Amgen	Rocatinlimab	NCT06527404	Prurigo Nodularis	2026-04-17
2026-07-23	Trial completed	AstraZeneca	Tozorakimab	MIRANDA	Chronic Obstructive Pulmonary Disease (COPD)	2026-03-06
2026-07-21	Trial completed	Merck	pembrolizumab	NCT04210115	Esophageal Adenocarcinoma (EAC), Esophageal Squamous Cell Carcinoma (ESCC), Gastroesophageal Junction Carcinoma (GEJC)	2026-01-21
2026-07-20	Trial completed	Roche	Satralizumab	SatraGO-2	Thyroid Eye Disease	2025-07-24
2026-07-16	Trial completed	Novo Nordisk	Cagrilintide, Semaglutide, Tirzepatide	REIMAGINE 5	Diabetes Mellitus, Type 2	2026-06-02
2026-07-16	Trial terminated	Amgen	Bemarituzumab	FORTITUDE-102	Gastric Cancer, Gastroesophageal Junction Adenocarcinoma	2025-10-14
2026-07-15	Trial terminated	Amgen	Rocatinlimab	ROCKET-ASCEND	Atopic Dermatitis	2026-07-01
2026-07-14	Trial completed	Eli Lilly	Baricitinib	BREEZE-AD-PEDS	Atopic Dermatitis	2022-04-24
2026-07-14	Trial completed	AbbVie	Bimatoprost SR	MAIA	Ocular Hypertension, Open-Angle Glaucoma	2026-06-19
2026-07-13	Trial withdrawn	Bayer	not stated on an experimental arm	SUNFLOWER	Endometrial Hyperplasia	2026-06-17
2026-07-12	Trial completed	GSK	BLU-5937	CALM-1	Cough, Refractory Chronic Cough	2025-12-17
2026-07-09	Trial completed	Sanofi	not stated on an experimental arm	NCT06805513	Erectile Dysfunction	2026-03-02
2026-07-08	Trial completed	Boehringer Ingelheim	not stated on an experimental arm	NCT06077864	Obesity	2026-06-01
2026-07-07	Trial completed	Roche	Satralizumab	SatraGO-1	TED, Thyroid Eye Disease	2025-07-08
2026-07-07	Trial withdrawn	Novo Nordisk	Cagrisema	NCT07357766	Obesity, Overweight	2027-11-29 (est.)
2026-07-06	Trial completed	BMS	Nivolumab	CheckMate 274	Various Advanced Cancer	2020-07-17
2026-07-01	Trial completed	Amgen	AMG 510	NCT04303780	KRAS p, G12c Mutated /Advanced Metastatic NSCLC	2022-08-02
2026-06-29	Trial completed	Novartis	VAY736	NEPTUNUS-1	Sjogren Syndrome	2025-05-07
2026-06-29	Trial completed	AbbVie	Risankizumab	KEEPsAKE2	Psoriatic Arthritis (PsA)	2020-06-22
2026-06-26	Trial completed	AbbVie	Atogepant	ATO-TOPIRAMATE	Migraine	2025-04-28
2026-06-24	Trial completed	AstraZeneca	not stated on an experimental arm	PROSPERO	Chronic Obstructive Pulmonary Disease (COPD)	2026-02-26
2026-06-23	Trial completed	AstraZeneca	Durvalumab	NCT03519971	Non-Small Cell Lung Cancer	2023-09-07
2026-06-22	Trial terminated	Merck	Cisplatin, Lenvatinib	NCT04949256	Metastatic Esophageal Squamous Cell Carcinoma	2025-05-08
2026-06-19	Trial completed	Merck	Pembrolizumab	NCT03834493	Prostatic Neoplasms	2022-12-12
2026-06-18	Trial completed	BMS	Bortezomib, Carfilzomib, Daratumumab, Dexamethasone, Elotuzumab, Ixazomib, Lenalidomide, Pomalidomide, bb2121	KarMMa-3	Multiple Myeloma	2026-04-13
2026-06-17	Trial terminated	AstraZeneca	Ravulizumab	ARTEMIS	CKD, Cardiac Disease, Cardiopulmonary Bypass	2025-10-07
2026-06-16	Trial completed	Eli Lilly	Ixekizumab, Tirzepatide	TOGETHER-PsO	Obesity, Psoriasis	2026-01-08
2026-06-11	Trial completed	BMS	Azacitidine	NCT03703375	Lymphoma, T-Cell	2021-02-10
2026-06-10	Trial completed	Roche	Alectinib, Crizotinib	NCT03194893	Neoplasms	2025-09-18
2026-06-07	Trial completed	Takeda	TAK-771	NCT05084053	Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), Multifocal Motor Neuropathy (MMN)	2025-10-28
2026-06-05	Trial completed	Roche	Faricimab	POYANG	Choroidal Neovascularization Secondary to Pathologic Myopia	2026-05-22
2026-06-05	Trial completed	Roche	Alectinib	NCT02838420	Anaplastic Lymphoma Kinase-positive Non-small Cell Lung Cancer	2018-05-31
2026-06-04	Trial completed	J&J	Daratumumab	AURIGA	Multiple Myeloma	2024-04-04
2026-06-04	Trial completed	J&J	Daratumumab SC: daratumumab + rHuPH20	NCT03301220	Smoldering Multiple Myeloma	2024-05-01
2026-06-03	Trial completed	Sanofi	NVX-CoV2705	COVID-19	COVID-19, SARS-CoV-2 Infection	2026-01-12
2026-06-02	Trial completed	Novartis	not stated on an experimental arm	NCT04516369	Biallelic RPE65 Mutation-associated Retinal Dystrophy	2022-04-05
2026-06-02	Trial completed	Gilead	Seladelpar 10 mg	IDEAL	Primary Biliary Cholangitis	2026-05-06
2026-06-02	Trial completed	Eli Lilly	Retatrutide	TRIUMPH-1	Obesity, Obstructive Sleep Apnea, Osteoarthritis, Knee	2026-04-06
2026-06-02	Trial completed	Eli Lilly	Mirikizumab IV, Mirikizumab SC	SHINE-2	Ulcerative Colitis	2026-05-01
2026-05-28	Trial completed	AbbVie	ABBV-951	NCT04750226	Parkinson's Disease (PD)	2026-04-27
2026-05-26	Trial completed	Roche	Atezolizumab, Bevacizumab	IMbrave050	Carcinoma, Hepatocellular	2022-10-21
2026-05-26	Trial completed	Merck	Pembrolizumab	KEYNOTE-866	Bladder Cancer	2026-01-26
2026-05-25	Trial completed	GSK	Cabotegravir (CAB) LA, DTG/3TC, Rilpivirine (RPV) LA	VOLITION	HIV Infections	2025-09-16
2026-05-22	Trial completed	Amgen	Bemarituzumab	FORTITUDE-101	Gastric Cancer, Gastroesophageal Junction Adenocarcinoma	2025-06-20
2026-05-20	Trial completed	Eli Lilly	Mirikizumab	LUCENT-URGE	Ulcerative Colitis, Ulcerative Colitis Chronic	2024-08-09
2026-05-20	Trial completed	Eli Lilly	Remternetug (IV), Remternetug (SC)	NCT05463731	Alzheimer's Disease	2024-04-24
2026-05-19	Trial completed	Pfizer	VLA15	VALOR	Lyme Disease	2026-01-07
2026-05-15	Trial completed	GSK	Bepirovirsen	NCT05630807	Chronic Hepatitis B, Hepatitis B, Chronic	2025-11-11
2026-05-13	Trial completed	Takeda	Antihemophilic Factor (Recombinant), Vonicog alfa	NCT02932618	Von Willebrand Disease	2026-04-17
2026-05-13	Trial completed	GSK	Bepirovirsen	NCT05630820	Chronic Hepatitis B, Hepatitis B, Chronic	2025-11-03
2026-05-12	Trial completed	Eli Lilly	Ixekizumab, Tirzepatide	TOGETHER-PsA	Obesity, Psoriatic Arthritis	2025-11-18
2026-05-11	Trial completed	J&J	Etravirine	NCT00980538	HIV Infections, HIV-1	2020-11-25
2026-05-11	Trial completed	AbbVie	ABBV-951	NCT04379050	Parkinson's Disease (PD)	2026-04-17
2026-05-07	Trial completed	Roche	Polatuzumab Vedotin	POLARIX	Diffuse Large B-Cell Lymphoma	2026-04-30
2026-05-07	Trial completed	J&J	Daratumumab	NCT03652064	Multiple Myeloma	2024-05-07
2026-05-04	Trial completed	Novartis	Iptacopan	APPELHUS	Atypical Hemolytic Uremic Syndrome	2026-04-11
2026-05-03	Trial completed	Novo Nordisk	Cagrilintide, Semaglutide	NCT06388187	Obesity	2026-04-22
2026-04-30	Trial completed	Merck	Olaparib, Pembrolizumab	NCT03740165	Fallopian Tube Cancer, Ovarian Cancer, Peritoneal Neoplasms	2024-08-26
2026-04-29	Trial completed	AbbVie	OnabotulinumtoxinA	NCT06794866	Forehead Lines	2026-04-03
2026-04-27	Trial completed	Takeda	Zasocitinib	NCT06973291	Plaque Psoriasis	2026-04-22
2026-04-27	Trial terminated	Sanofi	SAR408701	CARMEN-LC03	Non-small Cell Lung Cancer Metastatic	2023-09-22
2026-04-23	Trial completed	Boehringer Ingelheim	not stated on an experimental arm	SYNCHRONIZE™-2	Diabetes Mellitus, Type 2, Obesity	2025-12-12
2026-04-23	Trial completed	Amgen	Panitumumab, Sotorasib	CodeBreak300	Colorectal Cancer (CRC)	2025-07-16
2026-04-21	Trial completed	Novo Nordisk	Cagrilintide, Semaglutide	NCT06221969	Type 2 Diabetes	2026-03-04
2026-04-21	Trial terminated	Merck	Lenvatinib, Pembrolizumab	NCT04246177	Carcinoma, Hepatocellular	2025-08-19
2026-04-20	Trial completed	AstraZeneca	Baxdrostat	BaxAsia	Resistant Hypertension, Uncontrolled Hypertension	2025-11-24
2026-04-16	Trial completed	GSK	rMenB+OMV NZ vaccine	NCT06995430	Meningitis	2025-12-08
2026-04-16	Trial completed	Eli Lilly	Orforglipron	ACHIEVE-4	Cardiovascular Diseases, Chronic Kidney Disease, Obesity	2026-03-16
2026-04-15	Trial completed	Merck	Pembrolizumab	NCT04191096	Metastatic Hormone-Sensitive Prostate Cancer	2022-10-31
2026-04-15	Trial completed	AstraZeneca	Tozorakimab	TITANIA, OBERON 2 trials	Chronic Obstructive Pulmonary Disease (COPD)	2026-01-19
2026-04-10	Trial terminated	J&J	Aticaprant	VENTURA-LT	Depressive Disorder, Major	2025-04-25
2026-04-10	Trial completed	GSK	Niraparib	ZEAL-1L	Lung Cancer, Non-Small Cell	2025-02-26
2026-04-09	Trial completed	Merck	5-FU, Capecitabine, Lenvatinib, Leucovorin (or Levoleucovorin), Oxaliplatin, Pembrolizumab	NCT04662710	Advanced/Metastatic Gastroesophageal Adenocarcinoma	2024-10-29
2026-04-08	Trial completed	AstraZeneca	Ravulizumab	NCT04543591	Thrombotic Microangiopathy	2025-09-19
2026-04-07	Trial completed	Novo Nordisk	Semagludtide	EVOKE	Early Alzheimer's Disease	2025-09-16
2026-04-07	Trial completed	Novartis	TQJ230	NCT06267560	Elevated Lp(a) and Established Atherosclerotic Cardiovascular Disease	2026-03-25
2026-03-30	Trial completed	Bayer	8 mg aflibercept (BAY 86-5321) (High Dose)	PHOTONiC	Diabetic Macular Edema	2025-12-29
2026-03-30	Trial completed	AstraZeneca	Nirsevimab	JUBILUS	Respiratory Syncytial Virus Infections	2025-07-24
2026-03-26	Trial completed	J&J	Milvexian	LIBREXIA-ACS	Acute Coronary Syndrome	2026-02-06
2026-03-26	Trial terminated	Gilead	lenacapavir pacfosacil, lepetegravir, lepetegravir/lenacapavir pacfosacil FDC	WONDERS2	HIV-1-infection	2026-03-16
2026-03-25	Trial completed	Novo Nordisk	Semaglutide	EVOKE Plus	Early Alzheimer´s Disease	2025-09-15
2026-03-25	Trial terminated	Merck	Intismeran autogene, Pembrolizumab	INTerpath-007	Carcinoma, Squamous Cell, Skin Neoplasms	2026-03-05
2026-03-25	Trial completed	AstraZeneca	Nirsevimab	CHIMES	Lower Respiratory Tract Infection	2025-11-24
2026-03-23	Trial completed	Amgen	not stated on an experimental arm	ROCKET-Outpost	Atopic Dermatitis	2025-04-11
2026-03-20	Trial completed	Pfizer	Meningococcal (groups A, C, W-135 and Y [ACWY]) oligosaccharide diphtheria CRM197 conjugate vaccine, PF-06651600, Tetanus and diphtheria toxoids and acellular pertussis (Tdap) vaccine	ALLEGRO-LT	Alopecia Areata	2024-06-25
2026-03-20	Trial completed	Eli Lilly	Tirzepatide	NCT06047548	Obesity, Overweight	2026-01-20
2026-03-20	Trial completed	AbbVie	Azacitidine, Venetoclax	VIALE-M	Acute Myeloid Leukemia (AML)	2022-09-29
2026-03-18	Trial completed	Sanofi	Amlitelimab	NCT06181435	Dermatitis Atopic	2025-11-25
2026-03-16	Trial completed	Roche	Intravitreal Ranibizumab 0.5 mg Injection, PDS Implant Pre-Filled with 100 mg/mL Ranibizumab	PAVILION	Diabetic Retinopathy	2022-10-03
2026-03-16	Trial withdrawn	BMS	Fludarabine, Liso-cel	NCT06313996	Relapsed or Refractory Follicular Lymphoma	2031-10-16 (est.)
2026-03-11	Trial terminated	Novartis	Alpelisib, Olaparib	NCT04729387	Ovarian Cancer	2023-04-21
2026-03-06	Trial terminated	Novartis	alpelisib	EPIK-B3	Triple Negative Breast Neoplasms	2023-05-31
2026-03-06	Trial completed	Novartis	Secukinumab 150 mg, Secukinumab 300 mg	REPLENISH	Polymyalgia Rheumatica	2025-09-10
2026-03-06	Trial terminated	Eli Lilly	Lasmiditan	PIONEER-PEDS1, PIONEER-PEDS2 2 trials	Migraine	2025-11-12, 2025-12-04
2026-03-06	Trial terminated	Eli Lilly	Lasmiditan	PIONEER-PEDS1	Migraine	2025-11-12
2026-03-04	Trial completed	Novartis	ABL001 200mg QD, ABL001 40mg BID, ABL001 80mg QD	NCT04948333	Chronic Myelogenous Leukemia	2024-03-12
2026-03-02	Trial completed	Novartis	Tisagenlecleucel after optional bridging and lymphodepleting chemotherapy	BELINDA	Non-Hodgkin Lymphoma	2021-05-06
2026-02-24	Trial completed	Novartis	Secukinumab 150 mg, Secukinumab 300 mg	GCAptAIN	Giant Cell Arteritis (GCA)	2025-04-11
2026-02-24	Trial completed	GSK	DTG/3TC	EYEWITNESS	HIV, HIV Infections	2026-01-23
2026-02-23	Trial completed	Merck	Pembrolizumab	PEARLS	Non-small Cell Lung Cancer	2023-01-24
2026-02-23	Trial completed	Boehringer Ingelheim	not stated on an experimental arm	SYNCHRONIZE™-1	Obesity	2025-12-02
2026-02-12	Trial completed	Novo Nordisk	Oral semaglutide	PIONEER TEENS	Diabetes Mellitus, Type 2	2025-04-29
2026-02-12	Trial completed	Merck	Olaparib	NCT03976323	Carcinoma, Nonsquamous Non-small-cell Lung	2024-02-07
2026-02-05	Trial terminated	Novartis	canakinumab	CANOPY-1	Non-small Cell Lung Cancer	2021-08-09
2026-02-03	Trial completed	Merck	Pembrolizumab/Vibostolimab	NCT04738487	Lung Neoplasms, Non-Small-Cell Lung Carcinoma	2024-09-05
2026-02-03	Trial completed	Boehringer Ingelheim	survodutide	NCT06214741	Obesity, Overweight	2025-07-29
2026-02-02	Trial terminated	Roche	Tiragolumab	SKYSCRAPER-15	Non-small Cell Lung Cancer (NSCLC)	2025-12-16
2026-02-02	Trial completed	Merck	Pembrolizumab	NCT03867084	Hepatocellular Carcinoma	2025-03-20
2026-01-30	Trial terminated	Sanofi	High Dose (HD) RSVt vaccine, Low Dose (LD) RSVt vaccine, Standard Dose (SD) RSVt vaccine	OPAL	Healthy Volunteers, RSV Immunisation	2025-06-11
2026-01-21	Trial completed	Novo Nordisk	Cagrilintide, Semaglutide	REIMAGINE 2	Type 2 Diabetes Mellitus	2025-11-19
2026-01-16	Trial completed	AstraZeneca	Ravulizumab	NCT06578949	PNH, Paroxysmal Nocturnal Hemoglobinuria	2025-05-15
2026-01-13	Trial completed	Novo Nordisk	not stated on an experimental arm	REIMAGINE 1	Type 2 Diabetes	2025-10-01
2026-01-12	Trial completed	Sanofi	Eliglustat GZ385660, Imiglucerase GZ437843	ELIKIDS	Gaucher's Disease Type I, Gaucher's Disease Type III	2025-12-26
2026-01-12	Trial completed	Pfizer	Rimegepant	NCT05810038	Migraine	2025-08-25
2026-01-07	Trial completed	BMS	CC-93538	NCT04991935	Eosinophilic Esophagitis	2025-08-14
2026-01-06	Trial completed	Roche	Emicizumab	HAVEN 6	Hemophilia A, Mild Hereditary Factor VIII Deficiency Disease Without Inhibitor, Moderate Hereditary Factor VIII Deficiency Disease Without Inhibitor	2021-10-30
2026-01-01	Trial completed	Roche	Vamikibart	Sandcat	Uveitic Macular Edema	2025-05-07
2025-12-22	Trial completed	Merck	Sotatercept	NCT05818137	Pulmonary Arterial Hypertension	2024-03-12
2025-12-19	Trial completed	GSK	RSVPreF3 OA investigational vaccine	NCT06614725	Respiratory Syncytial Virus Infections	2025-06-03
2025-12-18	Trial completed	J&J	Bedaquiline	NCT04630145	Treatment-refractory Mycobacterium Avium Complex-lung Disease (MAC-LD)	2024-11-06
2025-12-18	Trial completed	Eli Lilly	Orforglipron	NCT06584916	Obesity, Overweight	2025-11-21
2025-12-17	Trial completed	AstraZeneca	ALXN2060	NCT04622046	Symptomatic Transthyretin Amyloid Cardiomyopathy	2023-11-08
2025-12-17	Trial completed	AstraZeneca	not stated on an experimental arm	FLAURA	Locally Advanced or Metastatic EGFR Sensitising Mutation Positive Non Small Cell Lung Cancer	2017-06-19
2025-12-16	Trial completed	Roche	Atezolizumab, Tiragolumab	SKYSCRAPER-06	Non-small Cell Lung Cancer (NSCLC)	2024-04-19
2025-12-15	Trial terminated	Eli Lilly	Baricitinib	COV-BARRIER	Corona Virus Infection, Covid19	2024-09-05
2025-12-11	Trial completed	Boehringer Ingelheim	not stated on an experimental arm	NCT06309992	Non-Alcoholic SteatoHepatitis (NASH), Obesity	2025-10-09
2025-12-10	Trial completed	Boehringer Ingelheim	Survodutide	SYNCHRONIZE™JP	Obesity	2025-12-03
2025-12-05	Trial completed	Amgen	Rocatinlimab	ROCKET-ASTRO	Atopic Dermatitis	2025-02-27
2025-12-05	Trial completed	AbbVie	BOTOX	MMP US P3 416	Masseter Muscle Prominence	2025-11-25
2025-12-04	Trial completed	J&J	Macitentan	TOMORROW	Pulmonary Arterial Hypertension	2024-08-28
2025-12-03	Trial completed	GSK	Mepolizumab	SPHERE	Hypereosinophilic Syndrome	2025-10-28
2025-12-01	Trial completed	Sanofi	Amlitelimab	SHORE	Dermatitis Atopic	2025-08-21
2025-11-28	Trial completed	AstraZeneca	Acalabrutinib	ASSURE	Chronic Lymphocytic Leukemia	2025-11-04
2025-11-24	Trial completed	Merck	Pembrolizumab, S-1	NCT03615326	Gastric Neoplasms, Gastroesophageal Junction Adenocarcinoma	2024-03-20
2025-11-20	Trial terminated	Sanofi	Acyclovir, Alemtuzumab GZ402673, Beta-Interferon, Ceterizine, Dexchlorpheniramine, Diphenydramine, Glatiramer acetate, Methylprednisolone, Other H1 antagonist, Paracetamol, Prednisolone, Ranitidine	LemKids	Multiple Sclerosis	2021-05-04
2025-11-19	Trial completed	Sanofi	Amlitelimab	COAST 1	Dermatitis Atopic	2025-07-23
2025-11-18	Trial completed	AbbVie	Upadacitinib	NCT03607422	Atopic Dermatitis	2021-03-11
2025-11-14	Trial completed	AbbVie	BOTOX	MMP US P3 417	Masseter Muscle Prominence	2025-11-10
2025-11-13	Trial completed	Takeda	TAK-771	NCT05513586	Primary Immunodeficiency Diseases (PID)	2025-10-30
2025-11-13	Trial completed	BMS	Mavacamten	ODYSSEY-HCM	Cardiomyopathy, Hypertrophic	2025-03-06
2025-11-12	Trial completed	Amgen	ABP 206	NCT05907122	Melanoma	2025-03-26
2025-11-11	Trial terminated	AbbVie	Paricalcitol	NCT04064827	Chronic Kidney Disease (CKD), Secondary Hyperparathyroidism (SHPT)	2025-06-09
2025-11-06	Trial completed	AstraZeneca	Baxdrostat	BaxHTN	Resistant Hypertension, Uncontrolled Hypertension	2025-05-21
2025-10-24	Trial completed	Roche	Atezolizumab, Tiragolumab	SKYSCRAPER-08	Esophageal Cancer	2023-02-13
2025-10-22	Trial completed	AbbVie	Upadacitinib	Measure Up 1	Atopic Dermatitis	2021-01-06
2025-10-14	Trial completed	GSK	GSK3511294 (Depemokimab)	NIMBLE	Asthma	2025-09-14
2025-10-13	Trial completed	GSK	RSVPreF3 OA investigational vaccine	NCT06551181	Respiratory Syncytial Virus Infections	2025-04-24
2025-10-12	Trial completed	Novo Nordisk	Somapacitan	REAL4	Growth Hormone Deficiency in Children	2021-11-10
2025-10-10	Trial completed	Novo Nordisk	Semaglutide	NCT05891496	Alzheimers Disease	2024-08-19
2025-10-03	Trial terminated	Takeda	Soticlestat	NCT05163314	Dravet Syndrome (DS), Lennox Gastaut Syndrome (LGS)	2025-09-24
2025-10-03	Trial terminated	Merck	Pembrolizumab/Vibostolimab	NCT05665595	Melanoma	2024-03-06
2025-10-01	Trial terminated	AbbVie	Azacitidine, Venetoclax	VIALE-T	Acute Myeloid Leukemia (AML), Cancer	2025-09-23
2025-09-30	Trial completed	AstraZeneca	Baxdrostat	Bax24	Resistant Hypertension	2025-08-17
2025-09-26	Trial completed	Sanofi	Itepekimab SAR440340	AERIFY-1, AERIFY-2 2 trials	Chronic Obstructive Pulmonary Disease	2025-04-11, 2025-04-21
2025-09-17	Trial completed	Merck	Pembrolizumab	NCT04934722	Metastatic Hormone-Sensitive Prostate Cancer	2022-10-31
2025-09-17	Trial completed	Eli Lilly	Orforglipron	ATTAIN-2	Obesity, Overweight, Type 2 Diabetes	2025-08-08
2025-09-15	Trial completed	AbbVie	Linaclotide	NCT05652205	Chronic Idiopathic Constipation (CIC), Functional Constipation (FC)	2025-09-02
2025-09-12	Trial completed	Pfizer	VLA15	NCT05634811	Lyme Disease	2025-07-21
2025-09-11	Trial completed	J&J	ExPEC9V	NCT04899336	Invasive Extraintestinal Pathogenic Escherichia Coli Disease (IED) Prevention	2025-08-27

A completed trial is not a result. The finding stays with the sponsor until it announces one, and the registry publishes the data itself about a year later - so this says an answer exists, never what it is. Terminations and withdrawals are shown for the same reason: a programme being abandoned is rarely announced at all. Dates are the registry's own, and a primary completion still marked "est." is the sponsor's forecast, which two thirds of trials pass without finishing. 19 older changes are held outside the window. Drawn from 10252 tracked Phase 3 trials.

Below large pharma #

The clinical-stage obesity and cardiometabolic companies most likely to surprise the giants - or be bought by them. Each row is a market filing from the last 365 days carrying a trial readout, a regulatory event or a deal, sorted newest first; the quoted line is from the filing itself. Click any column header to sort.

Trial readouts, regulatory events and deals at clinical-stage obesity and cardiometabolic companies
Date	Event	Company	Lead asset	Phase	From the filing
2026-08-27	Trial readout	MBX Biosciences	MBX 4291	Phase 1	The primary endpoint will evaluate the proportion of patients achieving a composite responder endpoint at Week 26, defined as meeting all the following criteria: • Maintenance of normal albumin-adjusted serum calcium levels • Independence from active vitamin D • Reducti
2026-08-14	Trial readout	Skye Bioscience	nimacimab	Phase 2	coiled-coil protein kinase Experienced management team with strong track record of successful drug discovery and development Fibrx Therapeutics will be Nasdaq listed Funded into 2029 through key value inflection points including RXC008 Phase 2 Topline data in FSCD in H2 2028 © 2 0 2 6 S ky e B io sc
2026-08-12	Trial readout	Altimmune	pemvidutide	Phase 2b	Altimmune Announces Second Quarter 2026 Financial Results and Business Update Initiated global PERFORMA Phase 3 trial in MASH Reported positive topline data from RECLAIM Phase 2 trial in AUD Completed patient enrollment in RESTORE Phase 2 trial in ALD $519 million in cash, cash equivalents and inves
2026-08-11	Regulatory	Aardvark Therapeutics	ARD-101	Phase 3	and Provides Business Updates Assessing unblinded Phase 3 HERO and OLE data for ARD-101 in PWS in the third quarter of 2026 to support an informed determination of next steps Remains in active discussions with the FDA to support resolution of the clinical hold for ARD-101 program $73.9 million in ca
2026-08-06	Trial readout	MBX Biosciences	MBX 4291	Phase 1	Quarter 2026 Financial Results and Corporate Highlights One-year data demonstrated sustained benefit of once-weekly canvuparatide as a potential PTH replacement therapy in chronic hypoparathyroidism; Phase 3 pivotal trial now recruiting Initial Phase 1 data for MBX 4291, a GLP-1/GIP co-agonist prodr
2026-08-05	Regulatory	Protagonist Therapeutics	PN-477	Phase 1	Protagonist Reports Second Quarter 2026 Financial Results and Provides Corporate Update ICOTYDE™ First Full Quarter of Commercial Sales with Strong Early Adoption Rusfertide NDA under Priority Review for Polycythemia Vera; PDUFA Date in August 2026 Comprehensive Phase 2b Program with PN-881, an Oral
2026-08-05	Trial readout	BioAge Labs	BGE-102	Phase 1	● The primary endpoint is percent change from baseline in hsCRP, a pharmacodynamic measure of NLRP3 pathway inhibition, over 12 weeks of dosing.
2026-07-28	Trial readout	Altimmune	pemvidutide	Phase 2b	Altimmune Announces Positive Topline Results from RECLAIM Phase 2 Trial of Pemvidutide in Alcohol Use Disorder Pemvidutide 2.4 mg delivered a statistically significant and clinically meaningful reduction in heavy drinking days, the primary endpoint of the trial Important secondary endp
2026-07-15	Trial readout	Fractyl Health	Revita	Pivotal	Now · Jul 2026 1 REMAIN-1 Midpoint Cohort 12-Mo randomized results Q3 2026 2 Fractyl Health ($GUTS) investor day Details coming soon Early Q4 2026 3 Pivotal topline: 6-month randomized trial results Late Q4 2026 4 Potential FDA De Novo submission 5 Potential clearance and launch with reimbursement i
2026-06-12	Trial readout	MBX Biosciences	MBX 4291	Phase 1	The primary endpoint was defined as maintaining albumin-adjusted serum calcium levels in the normal range and independence from conventional therapy (active vitamin D and >600 mg/day of calcium supplements).
2026-06-04	Trial readout	Veru	enobosarm	Phase 2b	topline and full data readout timing, scope and regulatory pathways for the continued development of enobosarm in patients with obesity, including the PLATEAU Phase 2b study; whether the PLATEAU trial will successfully meet any of its primary or secondary endpoints; and whether enobosarm in combinat
2026-06-04	Trial readout	Fractyl Health	Revita	Pivotal	We look forward to building on these open-label results with complementary one-year randomized data from our REMAIN-1 Midpoint Cohort in Q3 2026, followed by topline results from our REMAIN-1 Pivotal Cohort in early Q4 2026.” About REVEAL-1 The REVEAL-1 Cohort (n=22) is an open-label study in indivi
2026-05-14	Regulatory	Aardvark Therapeutics	ARD-101	Phase 3	Food and Drug Administration (FDA) has placed a full clinical hold on its investigational new drug application (IND) for ARD-101 related to the Company’s previously announced voluntary pause.
2026-05-13	Trial readout	Altimmune	pemvidutide	Phase 2b	Week Responder Analyses from the Phase 2b IMPACT Trial in MASH o A poster abstract: Effect of Pemvidutide on Cardiovascular Risk Factors in Patients with MASH: 48-Week Results from the Phase 2b IMPACT Trial Alcohol Use Disorder (AUD) ● Topline data from the RECLAIM Phase 2 trial of pemvidutide in AU
2026-05-12	Trial readout	Fractyl Health	Revita	Pivotal	• Early Q4 2026 : Topline 6-month randomized data from REMAIN-1 Pivotal Cohort.
2026-05-11	Trial readout	MBX Biosciences	MBX 4291	Phase 1	MBX Biosciences Provides Obesity Portfolio Update Including Initial Phase 1 Data for MBX 4291 Supporting Potential for Once-Monthly Dosing Preliminary blinded data from ongoing Phase 1 trial demonstrated mean weight loss of 7% (range 0-16%) at 8 weeks in first MAD Part B cohort (n=8, including 2 pla
2026-05-11	Trial readout	Fractyl Health	Revita	Pivotal	Key inclusion criteria: • Adults aged 35–70 with T2D • HbA1c between 7.0–10.0%, inclusive • BMI 27–40 kg/m² • On stable background therapy with GLP-1RAs and up to 3 non-insulin oral agents • Demonstrated tolerance and benefit from prior use of GLP-1RAs Primary endpoints include safety and tolerabili
2026-05-08	Trial readout	BioAge Labs	BGE-102	Phase 1	BioAge Labs Reports First Quarter 2026 Financial Results and Provides Business Updates Positive topline Phase 1 data for BGE-102, demonstrating potential best-in-class reductions among oral NLRP3 inhibitors in inflammatory biomarkers of cardiovascular risk Phase 2 dose-ranging proof-of-concept trial
2026-05-07	Regulatory	Scholar Rock	apitegromab	Phase 2	Financial Results and Recent Business Highlights • FDA accepted apitegromab Biologics License Application (BLA) for treatment of children and adults with spinal muscular atrophy (SMA) with September 30, 2026 Prescription Drug User Fee Act (PDUFA) action date • Accepted apitegromab BLA includes two f
2026-05-07	Trial readout	MBX Biosciences	MBX 4291	Phase 1	we are well positioned to execute on our goal of delivering improved, long-acting and well-tolerated peptide therapies for patients.” First Quarter 2026 and Corporate Highlights Once-Weekly Canvuparatide for Hypoparathyroidism • Presentation of Phase 2 results and one-year follow-up data in June : R
2026-03-31	Trial readout	Scholar Rock	apitegromab	Phase 2	Apitegromab is the first and only muscle-targeted therapy to demonstrate statistically significant and clinically meaningful improvements in motor function in a pivotal Phase 3 clinical trial in patients with SMA receiving treatment with an SMN-targeted therapy .
2026-03-24	Trial readout	Fractyl Health	Revita	Pivotal	• Early Q4 2026: Topline 6-month randomized data from REMAIN-1 Pivotal Cohort.
2026-03-24	Trial readout	BioAge Labs	BGE-102	Phase 1	BioAge Labs Reports Full Year 2025 Financial Results and Provides Business Updates from the Fourth Quarter of 2025 Positive interim Phase 1 data for BGE-102, a potent, structurally novel, orally available, brain-penetrant small-molecule NLRP3 inhibitor, demonstrating potential best-in-class reductio
2026-03-23	Trial readout	Aardvark Therapeutics	ARD-101	Phase 3	among patients who have successfully lost approximately 15% of body weight on GLP-1RA therapy, and the Phase 2 Sitagliptin and TAS2R for Weight Reduction with Exercise, Nutrition, and GLP-1RA Trial and Hunger Assessment (STRENGTH) trial to evaluate placebo-adjusted weight loss and the additive effec
2026-03-16	Trial readout	Structure Therapeutics	aleniglipron (GSBR-1290)	Phase 3	Structure Therapeutics Reports Positive Topline Data from Phase 2 ACCESS II Trial with Once-Daily Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron Placebo-adjusted mean weight loss of 16.3% (39 lbs) at 180 mg and 16.0% (37 lbs) at 240 mg at 44 weeks with no evidence of weight loss plateau
2026-03-12	Trial readout	MBX Biosciences	MBX 4291	Phase 1	for Hypoparathyroidism (HP) • End-of-Phase 2 FDA meeting for once-weekly canvuparatide completed: FDA feedback supported advancement into a Phase 3 trial and trial design elements have now been selected, including the number of patients, primary endpoint and key secondary endpoints, as well as dose
2026-03-09	Trial readout	MBX Biosciences	MBX 4291	Phase 1	Phase 3 trial design elements have now been selected, including the number of patients, primary endpoint (including proportion of participants who achieve normal serum calcium and independence from conventional therapy) and key secondary endpoints (including normalization of urinary calcium), as wel
2026-03-05	Trial readout	Altimmune	pemvidutide	Phase 2b	to evaluate multiple pemvidutide doses over a 52-week treatment period with biopsy-based endpoints to support potential accelerated approval o Company has submitted request for scientific advice to European regulators Alcohol Use Disorder (AUD) ● Topline data from RECLAIM Phase 2 trial of pemvidutid
2026-02-27	Regulatory	Aardvark Therapeutics	ARD-101	Phase 3	The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for Prader-Willi Syndrome (PWS).
2026-02-26	Trial readout	Fractyl Health	Revita	Pivotal	With randomization now complete and our balance sheet positioned to support us through and beyond the pivotal readout, our focus is on disciplined execution as we prepare to report topline 6-month results in early Q4 2026.
2026-02-26	Trial readout	Structure Therapeutics	aleniglipron (GSBR-1290)	Phase 3	Reports Fourth Quarter and Full Year 2025 Financial Results and Recent Highlights Positive results from the aleniglipron Phase 2 ACCESS programs in December 2025 demonstrated significant weight loss across all doses and up to 15.3% at 36 weeks Topline 44-week data from the ACCESS II study with highe
2026-02-10	Trial readout	Aardvark Therapeutics	ARD-101	Phase 3	The primary endpoint is change in the Hyperphagia Questionnaire for Clinical Trials (HQ-CT) score from baseline to Week 12.
2026-02-02	Trial readout	Skye Bioscience	nimacimab	Phase 2	The Company expects its current capital to fund projected operations and key clinical milestones into the fourth quarter of 2026, including topline data from the Phase 2a extension study of nimacimab and certain manufacturing and clinical activities, initial manufacturing runs needed to enable a sub
2026-01-29	Trial readout	Fractyl Health	Revita	Pivotal	loss experienced ~ 70% less post-GLP-1 weight regain with Revita vs sham at 6 months Results support pivotal study design and further substantiate Revita’s potential to be the first durable procedural therapy for post-GLP-1 weight maintenance; topline 6-month pivotal data and potential FDA filing ex
2026-01-20	Trial readout	BioAge Labs	BGE-102	Phase 1	The primary endpoint will be percent change in intraocular IL-6, with additional exploratory endpoints including best-corrected visual acuity (BCVA), central subfield thickness (CST) and intraocular and plasma biomarkers.
2026-01-12	Trial readout	Scholar Rock	apitegromab	Phase 2	HFMSE, Hammersmith Functional Motor Scale ‒ Expanded P-value reflects data from Primary Endpoint for SMA treatment population ages 2‒12.
2026-01-12	Trial readout	Protagonist Therapeutics	PN-477	Phase 1	• Topline 32 - Wk Primary EP results • 52 - Wk durability of response results VERIFY Ph 3, n = 293 • Kuykendall AT et al.
2026-01-12	Trial readout	BioAge Labs	BGE-102	Phase 1	BioAge Announces Additional Positive Interim Phase 1 Data for BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor, Demonstrating Potential for Best-in-Class hsCRP Reduction in Participants with Elevated Cardiovascular Risk First BGE-102 MAD cohort completed in obese individuals with elevated hsCRP rece
2025-12-19	Trial readout	Altimmune	pemvidutide	Phase 2b	(Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing therapies that address serious liver diseases, today announced positive topline results from the IMPACT Phase 2b trial of pemvidutide, a balanced 1:1 glucagon/GLP-1 dual receptor agonist, in patients with metabolic dysfunction
2025-12-10	Trial readout	Aardvark Therapeutics	ARD-101	Phase 3	Aardvark Therapeutics Announces First Patient Dosed in Australia in HERO Phase 3 Trial for Prader-Willi Syndrome Multiple active sites and strong US enrollment continue to support Q3 2026 timing for topline data readout Clinical trial sites in Canada and the United Kingdom have received regulatory c
2025-12-08	Trial readout	Structure Therapeutics	aleniglipron (GSBR-1290)	Phase 3	Structure Therapeutics Reports Positive Topline Data from ACCESS Program for its Once-Daily Oral Small Molecule GLP-1 Receptor Agonist, Aleniglipron Placebo-adjusted mean weight loss of 11.3% (27.3 lbs) with 120 mg dose in the 36-week Phase 2b ACCESS study with a 10.4% adverse event-related treat
2025-12-04	Trial readout	BioAge Labs	BGE-102	Phase 1	BioAge Announces Positive Interim Phase 1 Data for BGE-102, a Novel Brain-Penetrant NLRP3 Inhibitor BGE-102 was well-tolerated in SAD and initial MAD cohorts, with a pharmacokinetic profile supporting once-daily oral dosing Strong target engagement: BGE-102 achieved 90-98% suppression of IL-1β,
2025-12-02	Trial readout	Fractyl Health	Revita	Pivotal	clinical readouts from the ongoing REMAIN weight maintenance program: • January 2026: 6-month randomized data from the REMAIN-1 Midpoint Cohort • Q2 2026: 1-year REVEAL-1 Cohort data • Q3 2026: 1-year REMAIN-1 Midpoint Cohort data • H2 2026: Topline 6-month randomized data from REMAIN-1 Pivotal Coho
2025-12-01	Regulatory	Altimmune	pemvidutide	Phase 2b	Later this quarter, Altimmune has a scheduled End-of-Phase 2 meeting with U.S.
2025-11-12	Trial readout	Fractyl Health	Revita	Pivotal	The first co-primary endpoint is defined as the percent of total body weight regain from the time of tirzepatide discontinuation in Revita versus sham patients through 6-month follow up.
2025-11-06	Regulatory	Protagonist Therapeutics	PN-477	Phase 1	Protagonist Reports Third Quarter 2025 Financial Results and Provides Corporate Update Following the NDA submission for icotrokinra treatment of adults and adolescents with moderate to severe plaque psoriasis to the U.S.
2025-11-06	Trial readout	MBX Biosciences	MBX 4291	Phase 1	MBX Biosciences Reports Third Quarter 2025 Financial Results and Recent Corporate Highlights Reported positive topline results from the Phase 2 Avail™ trial of once-weekly canvuparatide in hypoparathyroidism (HP) Completed upsized public offering, raising approximately $200 million in gross proceeds
2025-11-06	Trial readout	Structure Therapeutics	aleniglipron (GSBR-1290)	Phase 3	“We are on schedule to report topline data by year-end 2025 from both the ACCESS and ACCESS II studies of aleniglipron, our once-daily oral small molecule GLP-1 receptor agonist for the treatment of obesity,” said Raymond Stevens, Ph.D., CEO of Structure Therapeutics.
2025-11-06	Deal	Altimmune	pemvidutide	Phase 2b	☐ Item 1.01 Entry into a Material Definitive Agreement On November 5, 2025, (the “Amendment Closing”), Altimmune, Inc.
2025-11-06	Trial readout	Aardvark Therapeutics	ARD-101	Phase 3	in Hyperphagia Questionnaire for Clinical Trials (HQ-CT) Score RANDOMIZATION SCREENING OLE PWS Patients W/Hyperphagia 10 years & older Open-Label Extension BASELINE MEASUREMENT WEEK 12 N=45 Treatment Arm A ARD-101 Treatment Arm B Placebo N=45 Primary endpoint: change in HQ-CT score from baseline to
2025-11-04	Regulatory	Aardvark Therapeutics	ARD-101	Phase 3	The FDA has granted ARD-101 both Orphan Drug Designation and Rare Pediatric Disease Designation for PWS.
2025-10-09	Trial readout	Aardvark Therapeutics	ARD-101	Phase 3	We look forward to our topline data readout for this potentially pivotal trial in the third quarter of 2026.” About ARD-101 ARD-101 is a gut-restricted small molecule agonist of select taste receptors (TAS2Rs) expressed in the intestinal lumen.
2025-10-06	Trial readout	Skye Bioscience	nimacimab	Phase 2	(the “Company”) issued a press release titled “Skye Bioscience Reports Topline CBeyond Phase 2a Data from Nimacimab Monotherapy and Combination Clinical Trial”.
2025-09-26	Trial readout	Fractyl Health	Revita	Pivotal	T2D and GLP-1 drug naiveAnticipated Milestones1 ?1-mo data: April 2025?3-mo data: June 2025•6-mo data: Q4 2025•1-yr data: Q2 2026 ?Enrollment: Q4 2024?3-mo data: Sept 2025•6-mo data: Q1 2026 ?Enrollment: Q2 2025•Randomization: Early 2026•6-mo primary endpoint and potential PMA filing: H2 2026 7 1.
2025-09-23	Regulatory	Scholar Rock	apitegromab	Phase 2	FDA Issues Complete Response Letter (CRL) for Apitegromab as a Treatment for Patients with Spinal Muscular Atrophy (SMA) Solely Related to Observations Identified at Catalent Indiana LLC Fill-Finish Facility · No other approvability issues cited in CRL · Scholar Rock intends to resubm
2025-09-22	Trial readout	MBX Biosciences	MBX 4291	Phase 1	MBX Biosciences Announces Once-Weekly Canvuparatide Achieved Primary Endpoint in Phase 2 Trial with 63% Responder Rate at 12 Weeks; 79% Responder Rate at 6 Months in Open-Label Extension Statistically significant responder rate achieved at 12 weeks with zero contribution from rescue therapy (PRN) an

Curated names, not the whole field: companies that file in the US, so a private or Asia-listed challenger appears only once a filer licenses its asset. A further 52 routine filings from these companies in the window - quarterly results, financings - are tracked but not shown. The event label is an automatic reading of the filing; the quoted line and the link are there to check it.

Company	New molecules	Label extensions	Other first approvals	Extensions per molecule
All 40 companies	132	931	102	7.1x
AbbVie	3	66	7	22.0x
Amgen	2	30	7	15.0x
Roche	5	71	6	14.2x
BMS	3	40	2	13.3x
Merck	8	101	4	12.6x
Eisai	1	12	1	12.0x
Regeneron	3	30	1	10.0x
J&J	6	58	10	9.7x
Novartis	7	58	7	8.3x
Boehringer Ingelheim	3	24	2	8.0x
argenx	1	8	1	8.0x
AstraZeneca	8	60	7	7.5x
Gilead	4	29	5	7.2x
Astellas	3	20	0	6.7x
Eli Lilly	6	39	4	6.5x
GSK	8	49	6	6.1x
Daiichi Sankyo	3	18	0	6.0x
Vertex	2	12	1	6.0x
Novo Nordisk	3	17	3	5.7x
Recordati	1	5	0	5.0x
Pfizer	9	44	6	4.9x
Incyte	2	9	2	4.5x
UCB	4	17	0	4.2x
Jazz	2	8	0	4.0x
Merck KGaA	1	4	0	4.0x
Bayer	4	14	1	3.5x
Sanofi	5	16	2	3.2x
Otsuka	2	6	1	3.0x
Genmab	1	3	0	3.0x
BioMarin	1	3	0	3.0x
Alnylam	1	3	0	3.0x
Servier	1	3	0	3.0x
Takeda	5	14	3	2.8x
Ipsen	3	6	0	2.0x
Neurocrine Biosciences	1	2	2	2.0x
Biogen	4	6	1	1.5x
Chiesi	3	4	1	1.3x
Teva	0	6	6	no new molecule
Viatris	0	8	3	no new molecule
Exelixis	0	5	0	no new molecule

New molecules vs label extensions #

Waiting on Brussels #

Filters #

The decisions #

Pivotal trials that just changed state #

Below large pharma #