Vifor asks FDA to take specific steps to stay actions the agency took in a 2020 citizen petition response purporting to change the established names a...
Federal Register notice: FDA announces a 10/6 Patient Engagement Advisory Committee meeting that will discuss and make recommendations on medical devi...
An FDA complete response letter asks FibroGen to conduct additional roxadustat clinical studies before resubmitting its NDA.
FDA warns Vivera Pharmaceuticals it is marketing unapproved, adulterated, and misbranded Covid-19 tests.
SterRx recalls three lots of sodium bicarbonate in 5% dextrose injection 150mEq per 1,000 mL due to waterborne microbial contamination.
CNN reports it has been told by two administration officials that it could be weeks until a permanent FDA commissioner is named.
FDA clears an Able Medical Devices 510(k) for its Mach Screw Clip System, a single-use, sterile screw delivery device.
FDA clears a 3NT Medical 510(k) for its single-use Peregrine Drivable Ear Nose and Throat Scope.