RHHBY FDA grants Priority Review to Roche's Gazyva/Gazyvaro for adults with primary membranous nephropathy
RHHBY FDA grants Priority Review to Roche's Gazyva/Gazyvaro for adults with primary membranous nephropathy
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Roche: FDA Grants Priority Review To Gazyva/Gazyvaro For Primary Membranous Nephropathy
* Priority Review Based On Phase III MAJESTY Results Showing Superiority Over Tacrolimus * Phase III MAJESTY: Complete Remission At Two Years Was 36.9% With Gazyva/Gazyvaro Vs. 5.7% With Tacrolimus * MAJESTY Study Data Submitted To Global Health Authorities, Including The European Medicines Agency * If Approved, Gazyva