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...
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 grants Jazz Pharmaceuticals accelerated approval for a BLA for Ziihera (zanidatamab-hrii) for treating unresectable or metastatic HER2-positive bi...
