FDA’s five NME approvals in June bring 1H24 total to 21

After a slow May in which FDA’s Center for Drug Evaluation and Research approved a single new molecular entity, five NME approvals in June brought 2Q24’s total to 11. With the 10 new drugs approved by CDER in 1Q24, it’s shaping up to be a middling year for U.S. approvals.  

Highlights among the June decisions included the accelerated approval of Iqirvo elafibranor, which Ipsen Group (Euronext:IPN; Pink:IPSEY) licensed from Genfit S.A. (Euronext:GNFT; NASDAQ:GNFT) in 2021, and the first-ever drug approval for 34-year-old  Geron Corp. (NASDAQ:GERN)...