On August 27, 2026, Roivant announced that the U.S. Food and Drug Administration (FDA) approved Brepocitinib (Lisraya), a TYK2/JAK1 inhibitor, 30 mg, for the treatment of adults with dermatomyositis (DM). Brepocitinib is a pill taken once daily. Lisraya represents the…

FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2 Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody to demonstrate a complete renal response benefit in lupus nephritis in…