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...
FDA commissioner Marty Makary reinstates CBER director Vinay Prasads previous additional duties as the agencys chief medical and scientific officer.
FDA approves an expanded indication to include pediatric patients aged one and older for AstraZenecas Koselugo to treat some cases of neurofibromatosi...
FDA publishes a draft guidance to assist in developing non-opioid analgesics to treat chronic pain.
