An FDA update on an ongoing investigation about a contaminant known as N-Nitrosodimethylamine found in ranitidine (Zantac) says that preliminary testi...
FDA clears an Xact Robotics 510(k) for its robotic system and its use during computed tomography guided percutaneous interventional procedures.
Thoratec Switzerland recalls its CentriMag Acute Circulatory Support System Motor, which is a component of the CentriMag Extracorporeal Blood Pumping ...
Federal Register notice: FDA determines that Boehringer Ingelheims Mexitil (mexiletine hydrochloride) was not withdrawn from sale for safety or effect...
FDA clears a Stryker 510(k) for its Sahara Lateral 3D Expandable Interbody System featuring Lamellar 3D Titanium Technology.
Sens. Warren, Murray, and Smith raise 18 additional questions for FDA to answer on its software pre-certification program.
FDA issues a draft guidance on changes affecting its implementation of GDUFA 2 user fees.
FDA accepts for review a Genentech BLA for satralizumab for treating adults and adolescents with neuromyelitis optica spectrum disorder.