Gazyva (obinutuzumab)
Search documents
Positive Phase III Results for Genentech's Gazyva in Children and Young Adults With Idiopathic Nephrotic Syndrome
Businesswire· 2025-10-28 06:00
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today statistically significant and clinically meaningful results from the Phase III INShore study of Gazyva® (obinutuzumab) in children and young adults (aged 2-25 years) with idiopathic nephrotic syndrome (INS). The study met its primary endpoint, with more people achieving sustained complete remission at one year (week 52) with Gazyva compared with mycophenolate mofet. ...
FDA Approves Genentech's Gazyva for the Treatment of Lupus Nephritis
Businesswire· 2025-10-20 05:00
Core Insights - The FDA has approved Gazyva® (obinutuzumab) for treating adult patients with active lupus nephritis (LN) who are on standard therapy [1] - The approval includes a new shorter infusion time of 90 minutes after the first infusion for eligible patients [1] - Gazyva can be administered twice a year following four initial doses in the first year [1]