FDA clears an Atmo Biosciences 510(k) for the ingestible Atmo Gas Capsule System for assessing both whole and regional gut transit times.
FDA publishes a question-and-answer guidance to help sponsors develop new antibacterial drugs.
Altimmune reports mixed topline results today from its Phase 2b IMPACT trial evaluating pemvidutide in patients with metabolic dysfunction-associated ...
FDA posts a draft guidance entitled Unique Device Identifier (UDI) Requirements for Combination Products.
Former CBER director Peter Marks says FDA should explain why it changed its Covid-19 vaccine policy in a way that did not promote transparency and gol...
FDA publishes a guidance with questions and answers on its various remote regulatory assessment tools.
FDA posts a final guidance entitled Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions.
FDA grants regenerative medicine advanced therapy designation for enGene Holdings bladder cancer drug detalimogene.
