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...
FDA posts two medical device guidances on orthopedic non-spinal bone plates and non-spinal metallic bone screws and washers.
FDA clears a Royal Philips 510(k) for remote scanning and remote protocol adjustment features on Philips Radiology Operations Command Center.
