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

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

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

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

The triple-drug combination of fixed-duration ibrutinib–venetoclax–obinutuzumab in the phase 3 GAIA-CLL13 trial involving fit patients (i.e., those with a low burden of coexisting conditions ...

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

Adding the anti-CD20 monoclonal antibody obinutuzumab (Gazyva) to standard therapy for lupus nephritis is more efficacious than standard therapy alone, according to a new phase 3, placebo ...

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 superior effects of obinutuzumab seen in the laboratory have been confirmed in clinical trials and, in 2013, the drug was the first drug to be awarded Breakthrough Therapy Designation by the ...

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

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

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® ...