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 ...

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

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

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 ...

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

Gazyva/Gazyvaro is an anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a CRR benefit in lupus ...

Bayer BAYRY announced its fourth-quarter and full-year 2024 results. AbbVie ABBV announced a licensing deal with Danish firm ...

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

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 ...

“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 ...