FDA publishes a draft guidance with recommendations for replacing color additives in approved or marketed drug products.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.
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...
FDA publishes two guidances relating to the CDRH/CBER Q-submission process.
