An appeals court rules for FDA that a clinically superior drug is not the same as a drug that is otherwise the same.
Achieve Life Sciences files an NDA for cytisinicline for treating nicotine dependence as part of smoking cessation in adults.
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FDA posts a draft guidance entitled Unique Device Identifier (UDI) Requirements for Combination Products.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...
