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.
Philips Respironics recalls (Class 1) its Garbin Evo ventilators due to the potential for aerosol deposit accumulation on the devices internal flow se...
