FDA accepts for review an Aldeyra Therapeutics NDA for reproxalap, an investigational topical new drug candidate for treating signs and symptoms of dr...
Federal Register notice: FDA permanently debars Ivette Maria Portela Martinez from providing services to a person that has an approved or pending drug...
Federal Register notice: FDA determines that Mercks Hydrocortone (hydrocortisone sodium phosphate) injection was not withdrawn due to safety or effect...
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 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...
