FDA posts a draft guidance entitled Recommended Follow-Up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Huma...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...
FDA approves a BridgeBio Pharma NDA for Attruby (acoramidis), a near-complete stabilizer of transthyretin for treating adults with transthyretin amylo...
