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

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 ...

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

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

Roche RHHBY announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its ...

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

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 ...

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