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...
FDA grants Adaptimmune an accelerated approval for its BLA for Tecelra (afamitresgene autoleucel), a gene therapy indicated for treating certain adult...
FDA grants Cellectis an orphan drug designation for CLLS52 (alemtuzumab), an investigational therapy for treating relapsed/refractory B-cell acute lym...
