The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva®) for the treatment of ...

For patients with active lupus nephritis, obinutuzumab, a humanized type II anti-CD20 monoclonal antibody plus standard ...

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® ...

The following is a summary of “Efficacy and Safety of Obinutuzumab in Active Lupus Nephritis,” published in the February 2025 ...

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 ...

Adding obinutuzumab to standard therapy for active lupus nephritis led to significantly higher rates of complete renal ...

Gazyva/Gazyvaro is an anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus ...

The CRISTALLO trial showed that venetoclax plus obinutuzumab achieved high minimal residual disease negativity as a frontline ...

The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for ...

Roche's filing is based on data from a late-stage study that shows a complete renal response benefit in lupus nephritis patients who received Gazyva.