FDA issues safety-related labeling updates for two bile acid transport inhibitors Mirum Pharmaceuticals Livmarli and Ipsen Biopharmaceuticals Bylvay ...
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FDA posts a draft guidance entitled Unique Device Identifier (UDI) Requirements for Combination Products.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.
