Merck and Eisai say results from the Phase 3 LEAP-015 trial evaluating Keytruda plus Lenvima in gastroesophageal adenocarcinoma patients missed its en...
FDA will review a Biogen sNDA for a Spinraza higher dose regimen.
FDA removes information and documents regarding several diversity-related initiatives and policies, presumably in response to a Trump Administration E...
Former FDA associate commissioner for womens health Susan Wood passes away at her home in London after battling glioblastoma (brain cancer).
FDA extends its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for treating Barth syndro...
FDA grants Zai Lab an orphan drug designation to ZL-1310, an antibody-drug conjugate for treating small cell lung cancer.
Three Ropes & Gray attorneys review major FDA-related enforcement cases in 2024 and say it is impossible to predict with certainty the direction the n...
Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.
