Atara Biotherapeutics says it and partner Pierre Fabre Pharmaceuticals have received feedback from FDA outlining a potential path toward resubmitting ...
FDA releases a new guidance outlining how drugmakers should design and conduct postapproval studies evaluating the safety of drugs and biologics used ...
CBER acting director Katherine Szarama discusses an expansive vision for the biologics center during remarks at the Food and Drug Law Institutes annua...
Pharmaceutical advertising experts react to FDAs dramatically altered enforcement approach toward prescription drug promotion since last fall.
Sanofi asks FDA to remove its Type 1 diabetes therapy Tzield from the agencys National Priority Voucher review program following an internal disagreem...
A Brookings Institution health economist voices support for FDAs revisions to a guidance on questions and answers about biosimilar development and the...
Five Hogan Lovells attorneys say a House Appropriations Committee report could prohibit FDA from accepting drug IND trial data from China, Russia, Nor...
FDA releases the form FDA-483 with 10 observations from a 2025 inspection at Indias Somerset Therapeutics Private Limited.
