News Related to CD20

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FDA Accepts Imlifidase BLA for Kidney Transplant Desensitization

Mar 06, 2026

The FDA has accepted Hansa Biopharma's Biologics License Application for imlifidase, a desensitization treatment for highly sensitized adult kidney transplant patients with positive crossmatch against deceased donors, with a PDUFA date of December 19, 2026.

Roche's Gazyva Meets Primary Endpoint in Phase III Kidney Disease Trial

Feb 16, 2026

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.