FDA warns Boston, MA-based TEI Biosciences about Quality System violations in its manufacturing of collagen-based products.
FDA removes a partial clinical hold against an Arcellx IND for CART-ddBCMA, an investigational drug for treating patients with relapsed or refractory ...
FDA approves Delcath Systems Hepzato Kit (melphalan for injection/hepatic delivery system) for liver-directed treatment in adult patients with uveal m...
Federal Register notice: FDA sends to OMB an information collection revision entitled Biologics License Applications (BLAs) Procedures and Requirement...
Federal Register notice: FDA seeks comments on an information collection extension entitled Registration of Human Drug Compounding Outsourcing Facilit...
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...
