US FDA approval tracker - February

 Backed by a positive panel meeting Johnson & Johnson’s JNJ-78436735 became the third Covid-19 vaccine granted US emergency use authorisation (EUA), but it is the first that requires only one dose. The company plans to deliver 100 million doses to the US during the first half of the year. An EUA was also granted to Lilly’s bamlanivimab plus etesevimab after the antibody combo significantly cut Covid-19-related hospitalisations and deaths in studies. February saw Bristol Myers Squibb’s Breyanzi become the third anti-CD19 Car-T therapy approved, and the project’s efficacy looks on a par with Gilead’s Yescarta, with less toxicity. However, Breyanzi is even more expensive to manufacture than existing Car-T products. Novartis’s Entresto gained approval in a broad heart failure population, but the group will need to make the most of this before generic competition hits. And Athenex had a knockback for Oraxol, a combination of oral paclitaxel and encequidar, in metastatic breast cancer. The FDA cited toxicity concerns and requested another clinical study. The Pdufa was scheduled for the last day of February and the news, released today, knocked half a billion dollars off the company's market cap.

Notable first-time US approval decisions in February
Project	Company	2026e sales by indication ($m)	Outcome
Breyanzi (liso-cel)	Bristol Myers Squibb	1,096	Approved
Oraxol (oral paclitaxel + encequidar)	Athenex	781	CRL
Cosela (trilaciclib)	G1 Therapeutics	583	Approved
Tepmetko (tepotinib)	Merck KGaA	505	Approved
Pepaxto (melphalan flufenamide/melflufen)	Oncopeptides	490	Approved
Ukoniq (umbralisib)	TG Therapeutics	296	Approved*
Defencath/Neutrolin	Cormedix	230	CRL
Amondys 45 (casimersen)	Sarepta	202	Approved
Posimir	Durect	195	Approved
StrataGraft	Mallinckrodt	59	Deferred (manufacturing inspection)
Nulibry (fosdenopterin)	Bridgebio	29	Approved
Evkeeza (evinacumab)	Sanofi/Regeneron	-	Approved
*Gained approval in marginal zone lymphoma and follicular lymphoma. Sources: EvaluatePharma & company releases. https://www.evaluate.com/vantage/articles/news/snippets/us-fda-approval-tracker-february-0