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...
FDA accepts for priority review a CytRx NDA for arimoclomol for treating Niemann-Pick disease Type C.
A Washington Post opinion piece takes issue with President Trump and his administrations meddling for political purposes in FDA and CDC activities rel...