[ Price : $8.95]
FDA issues a strategy document summarizing discussions at a 2025 workshop on developing interchangeable biosimilar products.[ Price : $8.95]
A KFF Health News report documents hundreds of FDA-mandated postmarket studies whose reports are listed as delayed.[ Price : $8.95]
FDA approves Ultragenyx Pharmaceuticals Fayuvi (rebisufligene etisparvovec-hopf), the first treatment for pediatric patients with ...[ Price : $8.95]
The Senate HELP Committee sets a 9/24 confirmation hearing on the nomination of Heidi Overton to be the next FDA commissioner.[ Price : $8.95]
Aquestive Therapeutics resubmits its NDA for Anaphylm (dibutepinephrine) sublingual film for treating Type I allergic reactions, i...[ Price : $8.95]
FDA publishes a longitudinal study of CDER first-cycle NDA and BLA review decisions that it says indicates there has not been a si...[ Price : $8.95]
FDA posts a draft guidance, Electronic Submission Template for Premarket Approval Applications (PMAs), outlining an eSTAR electron...[ Price : $8.95]
A RealClear Health column urges FDA not to overcorrect as it reconsiders its approach to investigational rare disease therapies.