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Merck and Daiichi Sankyo say they have withdrawn their BLA for the lung cancer drug patritumab deruxtecan.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FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.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 issues Stealth BioTherapeutics a complete response letter that proposes the company resubmit its elamipretide NDA to seek accelerated approval for...
FDA approves an Alcon NDA for Tryptyr (acoltremon ophthalmic solution) 0.003% for treating the signs and symptoms of dry eye disease.
