The FDA has approved obinutuzumab for the treatment of adults with active lupus nephritis who are receiving standard therapy, ...
FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody ...
FDA approval based on superiority of Gazyva over standard therapy alone, as shown in Phase II NOBILITY and Phase III REGENCY data –– Gazyva is the only anti-CD20 monoclonal antibody to demonstrate a ...
Investing.com -- The U.S. Food and Drug Administration (FDA) has approved Roche Holding AG’s (SIX:RO) Gazyva/Gazyvaro ...
Gazyva/Gazyvaro is the only anti-CD20 antibody to demonstrate a complete renal response benefit in lupus nephritis in a randomised phase III study2 Lupus nephritis is a debilitating condition that ...
FDA approval based on superiority of Gazyva/Gazyvaro over standard therapy alone, as shown in phase II NOBILITY and phase III REGENCY data1,2Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody t ...
Renalys Pharma reaches Japan PMDA agreement on phase III trials of sparsentan for FSGS and Alport syndrome: Tokyo, Japan Monday, October 20, 2025, 18:00 Hrs [IST] Renalys Pharma, ...
KDIGO's new IgA nephropathy guideline shifts the treatment paradigm from supportive care alone to targeting the disease's immunologic nature.
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Roche's Gazyva Secures FDA Nod for Label Expansion in Lupus Nephritis
Roche RHHBY announced that the FDA has approved a regulatory filing seeking the label expansion of Gazyva/Gazyvaro ...
Renalys Pharma, Inc. (Headquarters: Chuo-ku, Tokyo; "Renalys") today announced that it has reached an agreement with the Pharmaceuticals and Medical Devices Agency (PMDA) of Japan regarding ...
F. Hoffmann-La Roche Ltd: CHMP recommends EU approval of Roche's Gazyva/Gazyvaro for lupus nephritis
Positive recommendation based on phase II NOBILITY and phase III REGENCY data showing Gazyva/Gazyvaro's superiority over standard therapy alone1,2 Gazyva/Gazyvaro is the only anti-CD20 antibody to ...
(Nasdaq: EXEL) today announced results from a subgroup analysis of the CABINET phase 3 pivotal trial evaluating CABOMETYX ® (cabozantinib) versus placebo in patients with previously treated advanced ...
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