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 ...
Lupus Foundation of America2h
New Study Highlights the Impact of Flares and Persistently Active Disease on Organ Damage in People with Systemic Lupus Erythematosus
A new study sought to identify the frequency and determinants of flares for with people with systemic lupus erythematosus (SLE) with persistently active disease (PAD). Researchers found that both ...
PharmExec1d
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 ...
Lupus Foundation of America1d
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 ...
Pharmabiz16h
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 ...
pharmaphorum1d
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 ...
Contract Pharma1d
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 ...
Medical Dialogues1d
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 Letter1d
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 ...
Healio9h
Impacts of CAR T-cell therapy in lupus often ‘not captured on SLEDAI’
Chimeric antigen receptor T-cell therapy improves not only lupus disease activity but also other related conditions that ...
MPR1d
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 ...