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.
Moderna says its updated Covid-19 vaccine demonstrated a strong response against the new BA.2.86 variant that is being closely watched due to having o...
FDAs Oncology Center of Excellence and Flatiron Health renew a five-year collaboration to jointly develop and implement specific research projects to ...
FDA grants Admetsys a breakthrough device designation for its automated glucose control and continuous blood diagnostics system.
Seagen and Genmab report that their Phase 3 innovaTV 301 trial in recurrent or metastatic cervical cancer patients who received Tivdak (tisotumab vedo...
