Roche's Gazyva/Gazyvaro Receives FDA Priority Review for Rare Kidney Disease

The FDA has granted Priority Review to Roche's Gazyva/Gazyvaro for primary membranous nephropathy, a rare autoimmune kidney disease. This decision follows positive Phase III trial results showing the therapy's superiority in achieving complete remission. If approved, it would be the first FDA-sanctioned treatment for this condition, which currently lacks specific therapies.