A KFF Health News report documents hundreds of FDA-mandated postmarket studies whose reports are listed as delayed.
FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.
FDA approves Ultragenyx Pharmaceuticals Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with Sanfilippo syndrome ...
The Senate HELP Committee sets a 9/24 confirmation hearing on the nomination of Heidi Overton to be the next FDA commissioner.
Aquestive Therapeutics resubmits its NDA for Anaphylm (dibutepinephrine) sublingual film for treating Type I allergic reactions, including anaphylaxis...
FDA publishes a longitudinal study of CDER first-cycle NDA and BLA review decisions that it says indicates there has not been a significant increase i...
FDA posts a draft guidance, Electronic Submission Template for Premarket Approval Applications (PMAs), outlining an eSTAR electronic submission templa...
FDA finalizes a guidance intended to facilitate development of blood collection, processing and storage systems that would allow U.S. blood establishm...
