FDA clears an Akili 510(k) for EndeavorOTC (AKL-T01) as an over-the-counter treatment for adults with attention-deficit/hyperactivity disorder.
FDA publishes its report on an 11/2023 workshop on increasing clinical trial diversity.
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...
