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FDA posts a draft guidance entitled Recommended Follow-Up Testing for an Ames-Positive Drug (Active Ingredient) or Metabolite To Support First-in-Huma...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.
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...
Cassava Sciences discontinues the development of its Alzheimers disease drug simufilam after announcing disappointing topline data from the Phase 3 Re...
Merck stops early its Phase 3 ZENITH study evaluating Winrevair (sotatercept-csrk) in adults with pulmonary arterial hypertension due to positive stud...
