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...
FDA approves a Syndax Pharmaceuticals NDA for Revuforj (revumenib), a menin inhibitor for treating relapsed or refractory acute leukemia.
HHS secretary-nominee Robert F. Kennedy Jr. vows to free the agencies, including FDA, from the smothering cloud of corporate capture.
FDA accepts for review a Sanofi and Regeneron supplemental BLA resubmission for Dupixent (dupilumab) for treating chronic spontaneous urticaria.
