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Federal Register notice: FDA publishes a draft guidance entitled Nontuberculous Mycobacterial Pulmonary Disease Caused by Mycobacterium avium Complex ...
Federal Register notice: FDA posts a draft guidance entitled Post-Warning Letter Meetings Under GDUFA.
Federal Register notice: FDA withdraws 35 no-longer-marketed NDAs from multiple applicants.
