Merck and Daiichi Sankyo say they have withdrawn their BLA for the lung cancer drug patritumab deruxtecan.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FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.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.
Former McKinsey & Company senior partner Martin Elling is sentenced to six months in federal prison, supervised release after incarceration, community...