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...
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...
Capsida Biotherapeutics stops enrollment in its SYNRGY clinical trial that is evaluating gene therapy CAP-002 for treating STXBP1 developmental and ep...
