FDA publishes a table comparing the performance of over 50 Covid-19 molecular diagnostic tests.
FDA clears a Acutus Medical 510(k) for the second-generation AcQMap 3D imaging and mapping catheter.
Former FDA associate commissioner Peter Lurie says historic data on vaccine trials should lead to a realistic understanding that some or even all curr...
Federal Register notice: FDA proposes to reclassify Class 3 cytomegalovirus deoxyribonucleic acid quantitative assay devices intended for transplant p...
Federal Register notice: FDA withdraws the approval of two Eisai NDAs for weight loss drugs Belviq tablets and Belviq XR extended-release tablets due ...
FDA accepts for review a ChemoCentryx NDA for avacopan, an orally-administered selective complement 5a receptor inhibitor for treating antineutrophil ...
Two Florida men are charged as part of an Insys Subsys kickback and bribery scheme.
FDA dietary supplements director Steven Tave tells an industry conference about a regulatory gap between what the law requires and what enforcement ca...