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 ...
pharmaphorum3d
FDA starts review of Roche's Gazyva in lupus nephritis
The US regulator has started a review of Roche's supplemental biologics license application (BLA) for Gazyva/Gazyvaro ...
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 Dialogues3d
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 ...
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 ...
Pharmabiz2d
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 ...
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 ...
Morningstar4d
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a complete renal response benefit – – The filing application is based on data from the Phase III ...
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 ...
Nasdaq3d
Genentech : FDA Accepts SBLA For Gazyva For Lupus Nephritis Treatment
The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva plus standard therapy compared with standard ...