FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytruda (pembrolizumab) ...
FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.
FDA warns Switzerlands Levo AG about Quality System, Medical Device Reporting, and Unique Device Identifier violations in its production of several wh...
A 3/17-3/21 FDA inspection at the Guangxi Yulin Pharmaceutical Group drug manufacturing facility in Yulin, Guangxi, China, found repeated significant ...
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.
