FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal ...
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...
PharmExec3d
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 ...
Medical Dialogues4d
Roche Gazyva application accepted by USFDA for lupus nephritis
Gazyva/Gazyvaro is an anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus ...
Lupus Foundation of America4d
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 ...
MPR3d
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 ...
The Pharma Letter3d
FDA accepts Roche’s Gazyva/Gazyvaro sBLA for lupus nephritis
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for ...
Contract Pharma3d
FDA Accepts Roche’s sBLA for Lupus Nephritis Treatment
Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License ...
Pharmabiz3d
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 ...
Nasdaq4d
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
“The FDA’s sBLA acceptance for Gazyva recognizes the need to provide a more effective treatment option for people living with this devastating disease.” “Lupus nephritis is a debilitating ...
Business Wire4d
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
The FDA is expected to make a decision on approval by October 2025. “In people with lupus nephritis, Gazyva demonstrated a complete renal response benefit, a meaningful clinical outcome linked ...