FDA grants Admetsys a breakthrough device designation for its automated glucose control and continuous blood diagnostics system.
FDA posts an update on changes being made to the 510(k) program through three draft guidances.
The FDA Office of New Drugs announces a two-day meeting on PET drug issues and concerns.
Janssen says its Rybrevant met its progression-free survival endpoint in the MARIPOSA-2 lung cancer trial.
FDA denies an ICAN petition asking for changes to labeling for acellular pertussis vaccines to say they do not prevent infection or transmission of pe...
FDA issues Alexion a complete response letter on a supplemental BLA for long-acting C5 complement inhibitor Ultomiris and its use in treating certain ...
Federal Register notice: FDA makes available a final guidance entitled DSCSA Standards for the Interoperable Exchange of Information for Tracing of Ce...
FDA approves Boston Scientifics latest generation of its Watchman FLX Pro Left Atrial Appendage Closure device.
