Federal Register notice: FDA announces a 9/20 Vaccines and Related Biological Products Advisory Committee to discuss controlled human infection models...
FDA rejects a United Therapeutics citizen petition that asked it to withdraw tentative approval of a Liquidia Technologies NDA for Yutrepia (treprosti...
FDA clears a Guard Medical 510(k) for additional large sizes of surgical incision closures (wounds up to 25cm) for treatment with its next-generation ...
CDRH grants a de novo marketing authorization for SoCleans 3+ Bacterial Reduction Device, an over-the-counter product intended to be used as an adjunc...
FDA grants Daiichi Sankyo and AstraZeneca a breakthrough therapy designation for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating certain unrese...
FDA lifts a partial clinical hold on a MediLink Therapeutics and BioNTech Phase 1 trial evaluating BNT326/YL202 (NCT05653752), a HER3-targeted antibod...
Federal Register notice: FDA classifies into Class 2 devices that are intended to detect and identify nucleic acid targets in respiratory specimens fr...
FDA grants a de novo marketing authorization to NOWDiagnostics for its at-home First To Know Syphilis Test.
