Federal Register notice: FDA makes available a final guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.
Federal Register notice: FDA announces a 7/17 educational conference (public meeting) entitled First Annual Animal Drug User Fee Educational Conferenc...
A New York federal judge orders Stimwave founder and former CEO Laura Perryman to serve six years in jail for medical device healthcare fraud.
FDA asks for input on certain non-device software functions and impacts on patient safety.
Academic researchers say all 34 low molecular weight, protein-targeted, antineoplastic agents approved by FDA between 2019 and 2023 were facilitated i...
AstraZeneca says its CAPItello-290 Phase 3 trial of Truqap (capivasertib) in combination with paclitaxel in patients with locally advanced or metastat...
FDA Webviews newsroom closes Wednesday 6/19 in recognition of the federal holiday Juneteenth.
FDA issues a partial clinical hold on a BioNTech/Medilink Therapeutics Phase 1 clinical (NCT05653752) trial that is evaluating BNT326/YL202 in certain...
