Philips Respironics recalls (Class 1) certain DreamStation auto continuous positive airway pressure and auto bilevel positive airway pressure devices ...
FDA commissioner Martin Makary pens an online JAMA Viewpoint to explain why the agency is moving to rein in direct-to-consumer pharmaceutical advertis...
FDA publishes a guidance describing its use of some alternative tools in specified drug facility inspections.
Intercept Pharmaceuticals withdraws Ocaliva (obeticholic acid) from the U.S. market for treating primary biliary cholangitis, following an FDA request...
A USC Schaeffer Center for Health Policy and Economics white paper urges FDA to take several steps it says can modernize drug development.
The Securities and Exchange Commission agrees to accept a FibroGen payment of $1.25 million to resolve a case involving tampering with roxadustat clin...
A Clinical Trials Transformation Initiative meeting summary highlights four key issues discussed at its session on the state of clinical trials.
FDA schedules an 11/6 Digital Health Advisory Committee meeting to examine the rise of generative artificial intelligence in digital mental health med...
