Posted by Michael Wonder on 21 Apr 2026
FDA accepts application for Genentech’s Gazyva for the treatment of the most common form of lupus
20 April 2026 - Filing acceptance based on Phase 3 ALLEGORY data for Gazyva showing a significant reduction in disease activity compared with placebo in people with systemic lupus erythematosus.
Genentech announced today that the US FDA has accepted the company’s supplemental biologics license application for Gazyva (obinutuzumab) for the treatment of systemic lupus erythematosus.
