March is Kidney Month! In November 2024, the American College of Rheumatology (ACR) released a summary of their new guidelines for the screening, treatment, and management of lupus nephritis. What is ...

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

Lupus nephritis is a serious complication of lupus — and because it doesn’t always cause symptoms right away, it’s important to find it early. Talk to your lupus doctor about getting screened (tested) ...

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

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

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

Research shows multiple factors drive CKD risk in lupus nephritis, including nephritic flares, baseline hypertension, renal ...

A regulatory decision is expected by October 2025. The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva ®) for the ...

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

Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...

The FDA is expected to make a decision on approval by October 2025. “In people with lupus nephritis, Gazyva demonstrated a complete renal response benefit, a meaningful clinical outcome linked ...

“Lupus nephritis is a debilitating and potentially life-threatening condition that can lead to kidney failure and require dialysis or transplantation,” said Louise Vetter, President and Chief ...