A new Government Accountability Office report urges three key strategies for FDAs programs for advancing rare disease products.
A 2023 FDA inspection of Astellas Pharmas Shizuoka, Japan manufacturing facility leads to a one-item Form FDA-483.
FDA posts a draft guidance entitled Frequently Asked Questions Developing Potential Cellular and Gene Therapy Products.
FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating signs and symptoms of dr...
FDA sends an alert about safety concerns with the use of Getinge/Maquets VasoView HemoPro Endoscopic Vessel Harvesting Systems.
Federal Register notice: FDA seeks comments on an information collection revision entitled Prescription Drug User Fee Program.
Eyenovia decides to terminate its Phase 3 CHAPERONE study evaluating a drug-device combination of low-dose atropine as a potential treatment for pedia...
FDA approves a Syndax Pharmaceuticals NDA for Revuforj (revumenib), a menin inhibitor for treating relapsed or refractory acute leukemia.
