The ACLU files a lawsuit seeking to force FDA to release documents related to its ongoing safety review of mifepristone.
FDA says it is approving new labeling submitted by Sarepta Therapeutics for its gene therapy Elevidys (delandistrogene moxeparvovec-rokl) that include...
FDA grants Parabilis Medicines a fast track designation for FOG-001, a first-in-class inhibitor targeting the β-catenin:TCF interaction, for trea...
Medical ethicist Arthur Caplan voices concerns about human subject protection in clinical trials due to significant staff cuts at FDA and HHS.
A Wiley Rein petition filed for a client asks FDA to order the immediate withdrawal of Wells Pharmas compounded 100 mg indomethacin suppository.
FDA approves Shanghai Henlius Biologics Poherdy (pertuzumab-dpzb), the first interchangeable biosimilar to Genentechs Perjeta (pertuzumab), a HER2-tar...
University of Chicago researchers explain how difficult it will be to improve government oversight over social media influencer promotions for FDA-reg...
FDA qualifies glutamate hydrogenase as a biomarker to enhance liver safety monitoring in clinical trials.
