A new FDA safety alert says that results from a clinical trial assessing safety of Eisais weight-loss drugs Belviq and Belviq XR (lorcaserin) show a p...
FDA places a partial clinical hold on Innate Pharmas TELLOMAK Phase 2 trial that is evaluating lacutamabs efficacy and safety in patients with advance...
CDER director Janet Woodcock says enhancing postmarket safety initiatives and modernizing the Centers new drugs regulatory program are two of the top ...
Federal Register notice: FDA exempts powered wheeled stretchers from premarket notification (510(k)) requirements.
Federal Register notice: FDA makes available a draft guidance entitled Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters ...
Taro Pharmaceuticals recalls one lot of epilepsy/bipolar drug lamotrigine 100 mg tablets after it was found to have been cross-contaminated with a sma...
FDA clears an Aidoc 510(k) for its artificial intelligence component for flagging large-vessel occlusion in head computed tomography angiography scans...
Galemed recalls (Class 1) its Babi.Plus Pressure Relief Manifold system due to complaints about the device not holding pressure.