FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.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...
Veru announces positive topline results from its Phase 2b QUALITY clinical trial that is evaluating enobosarm when added to semaglutide (Novo Nordisks...
FDA accepts for review a Mitsubishi Tanabe Pharma America NDA resubmission for investigational ND0612, a continuous, subcutaneous infusion of liquid l...
