FDA approves a Johnson & Johnson BLA for Rybrevant (amivantamab-vmjw) plus Lazcluze (lazertinib) for the first-line treatment of certain adult patient...
FDA clears a SI-Bone 510(k) for the iFuse Torq TNT Implant System for pelvic fragility fracture fixation and sacroiliac joint fusion.
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...
FDA posts a final guidance entitled Product-Specific Guidance (PSG) Meetings Between FDA and ANDA Applicants Under GDUFA.
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...
