FDA approves a Medtronic PMA for its Symplicity Spyral renal denervation system for treating hypertension.
FDA delays a 12/16-expected review decision on a Bristol Myers Squibb and 2seventy bio supplemental BLA for Abecma (idecabtagene vicleucel) and its us...
Federal Register notice: FDA announces a 12/14 public meeting entitled Advancing the Development of Therapeutics Through Rare Disease Patient Communit...
Federal Register notice: FDA seeks information to better understand the status of trading partners interoperable systems and processes for enhanced dr...
A new final rule outlines five standards that the agency says drug marketers must follow to ensure their direct-to-consumer advertisements major state...
Bayer stops its Phase 3 OCEANIC-AF study evaluating asundexian compared to apixaban (Bristol-Myers Squibbs Eliquis) in patients with atrial fibrillati...
FDA warns healthcare professionals not to use Cardinal Health Monoject syringes with syringe pumps and patient-controlled analgesia pumps while the ag...
Janssen Pharmaceutical files a supplemental BLA for Rybrevant (amivantamab-vmjw) in combination with chemotherapy (carboplatin and pemetrexed) for tre...
