Three stakeholders raise concerns with an FDA guidance on gastroparesis drug development.
FDA grants Garwood Medical a Breakthrough Device designation for its BioPrax device for eliminating biofilm infections on prosthetic knees.
FDA approves a Vertex Pharmaceuticals NDA for Trikafta (elexacaftor/ivacaftor/tezacaftor), the first triple combination therapy to treat patients with...
FDA approves AstraZenecas Farxiga (dapagliflozin) to reduce the risk of hospitalization for heart failure in certain adults with Type-2 diabetes.
FDA approves an Alexion Pharmaceuticals BLA for Ultomiris (ravulizumab-cwvz) for treating atypical hemolytic uremic syndrome to inhibit complement-med...
FDA posts a Form-483 from a July inspection at Ram Pharmas Idaho Falls, ID outsourcing facility.
FDA makes available a draft guidance entitled Drug Master Files.