FDA denies a St. Jude Childrens Research Hospital request to allow some use of codeine-containing analgesics in patients under age 12.
FDA commissioner Robert Califf says dietary supplement risk management will be elevated with the integration of the Office of Dietary Supplement Progr...
Oncopeptides says it is going to file a formal appeal of FDAs recent request for the company to voluntarily withdraw its accelerated-approved multiple...
FDA sets 2/22/2024 as the PDUFA action date for its priority review of Venatorx Pharmaceuticals NDA for cefepime-taniborbactam to treat complicated ur...
FDA grants AngioDynamics a breakthrough device designation for its AngioVac System and its proposed indication for use to include the non-surgical rem...
Federal Register notice: FDA debars Ildiko M. Knoll for five years from importing or offering for import any drug into the U.S.
FDA extends by three months the review of a Valneva BLA for VLA1553, the companys chikungunya virus vaccine candidate.
Federal Register notice: FDA announces a modification to the organizational structure of CDRHs Office of Strategic Patnerships and Technology Innovati...
