Regeneron Pharmaceuticals wins FDA approval for high-dose Eylea HD (aflibercept) injection 8 mg after resolving inspection concerns at its contract ma...
FDA approves a Neurocrine Biosciences NDA for Ingrezza (valbenazine) capsules for treating adults with chorea associated with Huntingtons disease.
FDA places a partial clinical hold on Gilead Sciences studies evaluating magrolimab to treat acute myeloid leukemia.
FDA accepts for review a Geron NDA for imetelstat, a potential first-in-class telomerase inhibitor for treating transfusion-dependent anemia in patien...
Federal Register notice: FDA decides not to add ephedrine sulfate and hydroxychloroquine sulfate to its list of bulk drug substances that are acceptab...
Federal Register notice: FDA corrects an 8/14 notice that announced a modification to the organizational structure of CDRHs Office of Strategic Partne...
The U.S. Justice Department fines Teva Pharmaceuticals USA and Glenmark Pharmaceuticals over $300 million in deferred prosecution agreements involving...
HHS secretary Xavier Becerra announces that FDA commissioner Robert Califf will be heading soon to India to meet with Indian regulatory and drug indus...
