FDA posts an International Council for Harmonization draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharm...
FDA vaccines advisory committee chair Hana El Sahly recuses herself from reviewing any upcoming pandemic vaccines because of her role overseeing a Mod...
FDA issues Assure Tech an emergency use authorization for the first serology (antibody) point-of-care test for Covid-19.
Bristol Myers Squibb says an Opdivo (nivolumab) Phase 3 trial in patients post-surgery with high-risk, muscle-invasive urothelial carcinoma met its pr...
Federal Register notice: FDA makes available three final guidance documents for its Accreditation Scheme for Conformity Assessment Pilot Program.
FDA approves Vertex Pharmaceuticals Kalydeco (ivacaftor) for use in certain children with cystic fibrosis ages four months to less than six months old...
FDA approves GlaxoSmithKlines Nucala (mepolizumab) for adults and children aged 12 years and older with hypereosinophilic syndrome for six months or l...