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

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

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

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

In a new study, researchers investigated microRNA-203 as a potential biomarker for lupus nephritis (LN) and found that ...

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

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

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 ...

Merck’s lupus drug enpatoran has failed to meet the primary endpoint in a subgroup of patients, but the drug's development is ...

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

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

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