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 ...
FDA warns Medley, FL-based Lex, Inc., about repeat CGMP violations in its production of finished drugs as a contract facility.
Federal Register notice: FDA publishes a draft guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex ...
