FDA clears a B. Braun Medical 510(k) for its AQUAbase nX Reverse Osmosis System for providing high-quality water for dialysis patients.
FDA accepts for review a Verona Pharma NDA for ensifentrine for the maintenance treatment of patients with chronic obstructive pulmonary disease.
Federal Register notice: FDA makes available a draft guidance entitled Labeling for Biosimilar and Interchangeable Biosimilar Products.
FDA extends by 90 days its review of an Iovance Biotherapeutics BLA submission for lifileucel, a tumor infiltrating lymphocyte therapy for treating pa...
Federal Register notice: FDA makes available a final guidance entitled Annual Status Report Information and Other Submissions for Postmarketing Requir...
Federal Register notice: FDA makes available two draft guidances on clinical and non-clinical study recommendations for medical devices seeking indica...
Federal Register notice: FDA makes available a final guidance entitled Fostering Medical Device Improvement: Food and Drug Administration Activities a...
Federal Register notice: FDA makes available a final guidance entitled Breakthrough Devices Program.
