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

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® ...

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 ...

For patients with active lupus nephritis, obinutuzumab plus standard therapy is more efficacious than standard therapy alone.

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

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

Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License ...

The U.S. Food and Drug Administration (FDA) has accepted Genentech’s 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.

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

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 ...

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