Attorney Nathan Downing says medical product companies should review their professional promotions as strictly as they review direct-to-consumer mater...
Merck and Daiichi Sankyo say they have withdrawn their BLA for the lung cancer drug patritumab deruxtecan.
Eight congressional Democrats call on FDA to eliminate its new limits on Covid-19 vaccines.
FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.
FDA grants the Experimental Drug Development Center a fast-track designation for EBC-129 and its use for treating pancreatic ductal adenocarcinoma.
FDA grants Beam Therapeutics an orphan drug designation for BEAM-302, a liver-targeting lipid-nanoparticle that is designed to correct the disease-cau...
FDA warns Marburg, Germany-based DRG Instruments that it is marketing diagnostic devices that do not have FDA approval and are being manufactured with...
Complaining about a lack of information from the department, top Democrats on the House Energy and Commerce Committee ask HHS Secretary Robert F. Kenn...