CBER sends an untitled letter to AstraZeneca citing the firm for running a misleading television direct-to-consumer advertisement for its nasal spray ...
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...
CBER hosts a 10/22 virtual town hall focused on gene therapy manufacturing requirements for BLAs and post-licensure changes.
FDA under President Donald Trump advances plans discussed during the Biden Administration to scale back its long-standing practice of convening indepe...
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...
