FDA renews the Drug Safety and Risk Management Advisory Committee for an additional two years.
FDA grants Labcorp a de novo marketing authorization for its PGDx elio plasma focus Dx kitted assay.
FDA updates an Exactech recall involving its joint replacement devices manufactured between 2004 and 2021.
FDA grants META Pharmaceuticals a rare pediatric disease designation for META-001-PH, an investigational drug for treating primary hyperoxaluria.
FDA asks Actinium Pharmaceuticals for another Phase 3 study to support a BLA submission for Iomab-B in patients with active relapsed or refractory acu...
Federal Register notice: FDA announces the renewal of the Anesthetic and Analgesic Drug Products Advisory Committee for an additional two.
FDA approves Inspire Medical Systems Inspire V therapy system which includes the next generation neurostimulator for treating sleep apnea.
Federal Register notice: FDA makes available a final guidance entitled M12 Drug Interaction Studies and the supplemental document entitled M12 Drug In...
