FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis
Roche RHHBY announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its blockbuster drug Gazvya (obinutuzumab) as a potential treatment for lupus nephritis (LN).
Obinutuzumab Under Review for Treatment of Lupus Nephritis
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva®) for the treatment of
FDA Accepts Supplemental Biologics License Application for Gayzva for Treatment of Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for Gazyva® (Obinutuzumab), for the potential treatment of lupus nephritis, (LN,
FDA Accepts Roche’s Supplemental Biologics License Application for Gazyva/Gazyvaro in Lupus Nephritis
Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients with lupus nephritis who received Gazyva/Gazyvaro plus standard therapy achieved a complete renal response.
US FDA accepts Roche’s Gazyva/Gazyvaro sBLA for the treatment of lupus nephritis
US FDA accepts Roche’s Gazyva/Gazyvaro sBLA for the treatment of lupus nephritis: Basel Thursday, March 6, 2025, 09:00 Hrs [IST] Roche announced that the US Food and Drug Admini
FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva®/Gazyvaro® (obinutuzumab) for the treatment of lupus nephritis.
Genentech receives FDA acceptance for Gazyva sBLA
Genentech, a member of Roche (RHHBY), announced that the FDA has accepted the company’s supplemental biologics license application for Gazyva
Genentech gets FDA acceptance for its Lupus treatment's license application
Genentech, a Roche Group company(OTCQX:RHHBY) said on Wednesday that the U.S. FDA accepted the company’s supplemental Biologics License Application ((sBLA)) for Gazyva to treat lupus nephritis. Lupus nephritis is a type of kidney disease where the immune system attacks the kidneys.
Obinutuzumab efficacious for renal response in lupus nephritis
For patients with active lupus nephritis, obinutuzumab, a humanized type II anti-CD20 monoclonal antibody plus standard ...
Healio8d
Gazyva significantly boosts complete renal response rates in active lupus nephritis
Adding obinutuzumab to standard therapy for active lupus nephritis led to significantly higher rates of complete renal ...
Medscape17d
Obinutuzumab a Success in Phase 3 Trial for Lupus Nephritis
Adding the anti-CD20 monoclonal antibody obinutuzumab (Gazyva) to standard therapy for lupus nephritis is more efficacious than standard therapy alone, according to a new phase 3, placebo ...
Physician's Weekly9d
Obinutuzumab Shows Superior Renal Response in Active Lupus Nephritis
The following is a summary of “Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis,” published in the February 2025 ...
The New England Journal of Medicine29d
Fixed-Duration Acalabrutinib Combinations in Untreated Chronic Lymphocytic Leukemia
The triple-drug combination of fixed-duration ibrutinib–venetoclax–obinutuzumab in the phase 3 GAIA-CLL13 trial involving fit patients (i.e., those with a low burden of coexisting conditions ...
Nature6y
Obinutuzumab for the treatment of non-Hodgkin lymphomas
The superior effects of obinutuzumab seen in the laboratory have been confirmed in clinical trials and, in 2013, the drug was the first drug to be awarded Breakthrough Therapy Designation by the ...