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FDA accepts for priority review an Astellas supplemental BLA for Padcev (enfortumab vedotin-ejfv) in combination with Mercks Keytr...[ Price : $8.95]
FDA awards a fast track designation to Myosin Therapeutics and its investigational drug MT-125 for treating brain cancer.[ Price : $8.95]
FDA warns Switzerlands Levo AG about Quality System, Medical Device Reporting, and Unique Device Identifier violations in its prod...[ Price : $8.95]
A 3/17-3/21 FDA inspection at the Guangxi Yulin Pharmaceutical Group drug manufacturing facility in Yulin, Guangxi, China, found r...[ Price : $8.95]
FDA grants Quoin Pharmaceuticals an orphan drug designation for QRX003 and its use in treating Netherton syndrome.[ Price : $8.95]
FDA approves Genentechs Gazyva (obinutuzumab) for treating adult patients with active lupus nephritis who are receiving standard t...[ Price : $8.95]
FDA releases hiring data showing steep declines in staffing at CDER and CBER.[ Price : $8.95]
FDA warns St. Louis, MO-based BRS Analytical Services about CGMP violations in its production of finished drugs.