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...
FDA clears a DePuy Synthes 510(k) for its VELYS Robotic-Assisted Solution and its use in unicompartmental knee arthroplasty.
FDA approves an Octapharma supplemental NDA for the expanded approval of Fibryga (fibrinogen) for fibrinogen replacement in bleeding patients with acq...
