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...
The 5th Circuit Court of Appeals overrules a Texas federal court and says a suit by three doctors against FDA and HHS and their top officials over mes...
FDA clears a Techsomed 510(k) for its VisAble.IO software intended to assist physicians in planning liver ablation procedures and confirming ablation ...
