Based on just-reported Phase 3 trial data, Axsome Therapeutics says it will submit an NDA for on AXS-12 (reboxetine) and its use in treating narcoleps...
FDA posts a draft guidance entitled Recommended Follow-Up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Huma...
FDA releases the form FDA-483 with six observations from an inspection at Limerick, Ireland-based Regeneron Ireland Designated Activity Company.
President-elect Donald Trump names Johns Hopkins surgeon and public policy researcher Marty Makary as his nomination to be the next FDA commissioner.
FDA issues a final guidance entitled Transitional Enforcement Policy for Ethylene Oxide Sterilization Facility Changes for Class 3 Devices.
FDA approves a Zimmer Biomet PMA supplement for its Oxford Cementless Partial Knee.
FDA accepts for review an Alnylam Pharmaceuticals supplemental NDA for vutrisiran, an investigational RNAi therapeutic in development for treating tra...
