Zenyaku Kogyo obtained Japanese regulatory approval for Rituxan (rituximab) as a treatment for autoimmune hemolytic anemia, a government-designated intractable disease. The approval follows a public knowledge-based application submitted in August 2025.
Roche announced that Gazyva/Gazyvaro met its primary endpoint in the Phase III MAJESTY study for primary membranous nephropathy, showing statistically significant complete remission rates versus tacrolimus. The drug could become the first approved therapy for this rare autoimmune kidney disease.
Genentech's Phase III MAJESTY study showed Gazyva achieved statistically significant complete remission rates versus tacrolimus in primary membranous nephropathy, a chronic autoimmune kidney disease affecting over 96,000 people in the U.S.