FDA grants Quoin Pharmaceuticals an orphan drug designation for QRX003 and its use in treating Netherton syndrome.
FDA approves Genentechs Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis who are receiving standard therapy.
FDA releases hiring data showing steep declines in staffing at CDER and CBER.
FDA warns St. Louis, MO-based BRS Analytical Services about CGMP violations in its production of finished drugs.
GSK and Spero Therapeutics report positive Phase 3 results for tebipenem HBr, an investigational oral antibiotic for complicated urinary tract infecti...
FDA says it is strengthening labeling for tranexamic acid injection products to clarify that it is only to be administered intravenously.
FDA contracts with the Institute for Safe Medication Practices for services to strengthen its ability to identify and reduce the risk of medication er...
FDA hosts a one-day public workshop 10/23 to explore new approaches for approving patch test allergens used in diagnosing allergic contact dermatitis.
