Roche heads to regulators with new autoimmune win for Gazyva
Continuing the reinvention of its cancer drug Gazyva as a treatment for immune-mediated diseases of the kidney—which resulted…
Roche defends 6B franc Vabysmo peak target despite another miss
Roche’s Vabysmo disappointed investors again. In the second quarter, the eye drug’s sales of about 1.04 billion Swiss…
FDA grants Priority Review to Roche’s Gazyva/Gazyvaro for adults with primary membranous nephropathy
F. Hoffmann-La Roche Ltd Priority Review decision is based on phase III MAJESTY results, where Gazyva/Gazyvaro achieved significantly…
Roche Gazyva/Gazyvaro Gets FDA Priority Review
Roche (OTCQX:RHHBY) reported that the US FDA granted Priority Review to its supplemental Biologics License…
Roche Q1 earnings suffer blood bath thanks to currency headwinds
Editor’s Note: The original version of the story was based on consensus estimates cited by ODDO BHF. We’ve…
Roche lupus drug Gazyva gets FDA filing acceptance
Roche (OTCQX: RHHBY) said the FDA accepted its supplemental BLA for Gazyva/Gazyvaro (obinutuzumab)…
Roche’s Gazyva wins EU nod for adults with active lupus nephritis
Roche (RHHBY) announced that the European Commission approved Gazyva/Gazyvaro (obinutuzumab) on 9 December 2025 for adults with active…
Roche lupus drug cuts disease activity in phase III
Roche (OTCQX: RHHBY) announced NEJM publication of phase III ALLEGORY data showing Gazyva/Gazyvaro (obinutuzumab) plus standard therapy significantly…
How Investors Are Reacting To Roche Holding (SWX:ROG) FDA Approval and Breakthrough Clinical Trial Results
Roche announced a series of major product milestones, including FDA approval for Gazyva in lupus nephritis and positive…
Roche’s Gazyva Meets Phase III SLE Endpoints at 52 Weeks
Roche (RHHBY) announced on 3 November 2025 that the phase III ALLEGORY study…
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European Commission approves Roche’s Gazyva/Gazyvaro for adults with active lupus nephritis
F. Hoffmann-La Roche Ltd Approval based on phase II NOBILITY and phase III REGENCY studies showing superiority of…
Roche announces positive phase III results for Gazyva/Gazyvaro in primary membranous nephropathy, marking a significant milestone in this autoimmune disease
F. Hoffmann-La Roche Ltd MAJESTY, the first global phase III study in primary membranous nephropathy, met its primary…