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

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 ...

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

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 ...

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

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

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

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.

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

The price you pay for Gazyva depends on factors such as your dosage, whether you have health insurance, and the pharmacy you use. Financial assistance may be available to help you with the cost of ...