The FDA has agreed to review an application from Roche that seeks approval in the U.S. of obinutuzumab as a treatment for ...

A new study published in the Journal of American Medical Association showed that when taken with glucocorticoids for ...

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 important for a patient ...

A minimum of 3 years of sustained clinical remission may protect against an increase in disease activity and the development ...

More than one-third of patients with systemic lupus erythematosus experience a flare after starting dialysis for end-stage ...

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 ...

“The FDA’s sBLA acceptance for Gazyva recognizes the need to provide a more effective treatment option for people living with this devastating disease.” “Lupus nephritis is a debilitating ...

Adding anifrolumab to standard treatment for systemic lupus erythematosus ... Adding obinutuzumab to standard therapy for active lupus nephritis led to significantly higher rates of complete ...

for the treatment of lupus nephritis. The filing acceptance is based on positive results from the Phase III REGENCY study, which showed improved complete renal response (CRR) with Gazyva plus ...