FDA approves seven NMEs in December

FDA approved seven new molecular entities in December, bringing the total for the year to 46. Down from 50 in 2024 and 55 in 2023, the count does not break any records but is in line with recent years. See an analysis by BioCentury for an assessment of the innovativeness of the 2025 approvals. 

Six of the seven December approvals were for products from biotechs and specialty pharmas. Three will be their makers’ first U.S. product launches: Cardamyst etripamil from  Milestone Pharmaceuticals Inc. (NASDAQ:MIST), Lerochol lerodalcibep from Lib Therapeutics Inc., and Myqorzo aficamten from Cytokinetics Inc. (NASDAQ:CYTK). ...