lupus, FDA and Roche

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 response benefit1 The filing application is based on data from the phase III REGENCY study,
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.
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
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 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).
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.
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 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 Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Gazyva® (obinutuzumab) for the treatment of lupus nephritis.
Lupus Foundation of America3h
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 ...
Turning pain into purpose: How one Cape Town runner aims to support a brave teen battling lupus
In standing together, we can ensure that Mercédi’s fight with lupus is not her fight alone. A community mobilised by empathy ...
Healio10h
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 ...
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 ...
Lupus Foundation of America6d
New Study Investigates the Role of microRNA-203 as a Potential Biomarker for Lupus Nephritis
In a new study, researchers investigated microRNA-203 as a potential biomarker for lupus nephritis (LN) and found that ...
Daily6d
Second-Trimester Kidney Function Tied to Adverse Pregnancy Outcomes: Study
USA: Researchers have found in a new study that kidney function during the second trimester plays a crucial role in ...