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Merck and Eisai say results from the Phase 3 LEAP-015 trial evaluating Keytruda plus Lenvima in gastroesophageal adenocarcinoma pa...[ Price : $8.95]
FDA will review a Biogen sNDA for a Spinraza higher dose regimen.[ Price : $8.95]
FDA removes information and documents regarding several diversity-related initiatives and policies, presumably in response to a Tr...[ Price : $8.95]
Former FDA associate commissioner for womens health Susan Wood passes away at her home in London after battling glioblastoma (brai...[ Price : $8.95]
FDA extends its review of a Stealth BioTherapeutics NDA for elamipretide, a first-in-class mitochondria-targeted therapeutic for t...[ Price : $8.95]
FDA grants Zai Lab an orphan drug designation to ZL-1310, an antibody-drug conjugate for treating small cell lung cancer.[ Price : $8.95]
Three Ropes & Gray attorneys review major FDA-related enforcement cases in 2024 and say it is impossible to predict with certainty...[ Price : $8.95]
Two medical device stakeholders suggest ways for FDA to regulate generative AI and foundation model-enabled medical devices.