FDA issues a complete response letter to Xspray Pharmas NDA for Dasynoc, raising issues about a third-party manufacturer.
FDA grants Ultragenyx Pharmaceutical accelerated approval for its Genglycos (pariglasgene brecaparvovec-opnr) for adults and children eight years and ...
FDA warns Dayton, NJ-based Safrel Pharmaceuticals about CGMP violations in its manufacturing of finished drugs.
Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.
FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on developing and using digitally derived measures in cl...
Medline issues a device correction (Class 1 recall) for convenience kits containing B. Brauns bupivacaine hydrochloride components.
Academic researchers worldwide say FDA and other regulators must approve artificial intelligence/machine learning-enabled devices based on patient-cen...
FDA approves Regnerons Pasatru (garetosmab-grts) for reducing new heterotopic ossification (bone formation outside the skeleton) in adults with fibrod...
