FDA grants Longeveron a Regenerative Medicine Advanced Therapy designation for Lomecel-B and its use for treating mild Alzheimers Disease.
FDA publishes a guidance recommending principles for use in pivotal clinical studies to demonstrate the safety and effectiveness of medical devices tr...
Kazia Therapeutics says it will meet with FDA about a potential accelerated approval pathway for its glioblastoma drug paxalisib following positive ov...
Federal Register notice: FDA announces an 8/6 public workshop entitled Artificial Intelligence (AI) in Drug & Biological Product Development.
Federal Register: FDA schedules an 8/2 advisory committee meeting to discuss a Zevra Denmark A/S NDA for arimoclomol, indicated for treating Niemann-P...
FDA clears ImmersiveTouchs ImmersiveAR virtual and augmented reality operating room platform.
CBER issues a standard operating policy and procedure staff guide on administrative processing and review management procedures for INDs received by t...
AdvaMedDx calls for two substantive changes to an FDA draft guidance on the enforcement policy for certain in vitro diagnostic devices for immediate p...
