MPR21h
Obinutuzumab Under Review for Treatment of Lupus Nephritis
The Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for obinutuzumab (Gazyva®) for the treatment of ...
PharmiWeb4h
FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
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® ...
Pharmabiz10h
US FDA accepts Roche’s Gazyva/Gazyvaro sBLA for the treatment of lupus nephritis
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 Pharma Letter23h
FDA accepts Roche’s Gazyva/Gazyvaro sBLA for lupus nephritis
The US Food and Drug Administration (FDA) has accepted the supplemental Biologics License Application (sBLA) for ...
PharmExec19h
FDA Accepts Roche’s Supplemental Biologics License Application for Gazyva/Gazyvaro in Lupus Nephritis
Submission is supported by positive results from the Phase III REGENCY trial, which demonstrated that nearly half of patients ...
Contract Pharma22h
FDA Accepts Roche’s sBLA for Lupus Nephritis Treatment
Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License ...
Zacks.com on MSN22h
FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis
Roche's filing is based on data from a late-stage study that shows a complete renal response benefit in lupus nephritis patients who received Gazyva.