FDA approves a Medtronic PMA for the SenSight Directional Lead System used for deep brain stimulation therapy.
FDA approves an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) injection and its use in treating patients aged one month and older with ...
FDA lifts clinical holds against Bluebird Bios Phase 1/2 (HGB-206) and Phase 3 (HGB-210) studies of LentiGlobin gene therapy for sickle cell disease. ...
FDA approves a ProMetic Biotherapeutics BLA for Ryplazim (plasminogen, human-tmvh) for treating patients with plasminogen deficiency Type 1.
FDA Review posts the Federal Register notices for the week ending 6/4/2021.
Federal Register notice: FDA posts a draft guidance on drug supply chain definitions of suspect and illegitimate products.
Federal Register notice: FDA makes available a final guidance entitled Product Identifiers Under the Drug Supply Chain Security Act: Questions and Ans...