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 Review posts the Federal Register notices for the week ending 10/18/2019.
FDA Review posts product approval summaries for the week ending 10/18/2019.
FDA clears an Ortho Clinical Diagnostics 510(k) for the ORTHO Sera, a series of extended antigen phenotyping for use on the Ortho Vision Analyzer.
Federal Register notice: FDA makes available a draft guidance entitled Drug Master Files.