A coalition of 20 state attorneys general urge the Trump administration to tighten or suspend an FDA import program, alleging that Chinese suppliers a...
FDA cites Connecticut outsourcing facility Brookfield Medical/Surgical Supplies for inadequate investigations involving 13 out-of-specification potenc...
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...
