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...
Federal Register notice: FDA announces a 9/7-8 Medical Devices Advisory Committee Microbiology Devices Panel meeting that will discuss certain in vitr...
