[ Price : $8.95]
FDA lifts a partial clinical hold on a MediLink Therapeutics and BioNTech Phase 1 trial evaluating BNT326/YL202 (NCT05653752), a H...[ Price : $8.95]
FDA posts a final guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA.[ Price : $8.95]
Federal Register notice: FDA announces a 9/20 Vaccines and Related Biological Products Advisory Committee to discuss controlled hu...[ Price : $8.95]
FDA rejects a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for...[ Price : $8.95]
FDA clears a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with ...[ Price : $8.95]
Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify nucleic acid targets in resp...[ Price : $8.95]
FDA grants a de novo marketing authorization to NOWDiagnostics for its at-home First To Know Syphilis Test.[ Price : $8.95]
Federal Register notice: FDA classifies intravenous catheter force-activated separation devices into Class 2 (special controls).