21/04/2026 FDA accepted application for Roche’s Gazyva for the treatment of SLE FDA accepted application for Roche’s Gazyva for the treatment of SLE ( Ref ) Roche announced that the US FDA had accepted a supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab; anti-CD20) for the treatment of patients with systemic lupus erythematosus (SLE). The filing acceptance was based on positive results from the phase 3 ALLEGORY/ NCT04963296 study, which dem