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

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

Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal ...

Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients ...

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

The US regulator has started a review of Roche's supplemental biologics license application (BLA) for Gazyva/Gazyvaro ...

The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...

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

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

for obinutuzumab (Gazyva ®) for the treatment of lupus nephritis. Obinutuzumab is a monoclonal antibody that targets the CD20 receptor on B-cells. By depleting disease-causing B-cells ...