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...
Federal Register notice: FDA determines that Accord Healthcares bortezomib solution was not withdrawn due to safety or effectiveness reasons.
Federal Register notice: FDA denies a request for a hearing and permanently debars David Roy Winne from providing services related to an approved or p...
