FDA makes available a draft guidance entitled Drug Master Files.
Several lawmakers write FDA acting commissioner Ned Sharpless seeking more information about a recent Takeda Pharmaceuticals recall of its hypoparathy...
Bayer submits a supplemental NDA to extend the duration of use for its intrauterine device Mirena (levonorgestrel-releasing intrauterine system) 52 mg...
FDA clears a Canon Medical Systems 510(k) for its Advanced Intelligent Clear-IQ Engine (AiCE) for use on the Aquilion Precision CT Scanner.
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...