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 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FDA posts a draft guidance entitled Unique Device Identifier (UDI) Requirements for Combination Products.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.
