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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® ...
Pharmabiz13h
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 ...
PharmExec21h
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 ...
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FDA Accepts RHHBY's sNDA for Gazyva in Treating Lupus Nephritis
Roche RHHBY announced that the FDA has accepted its supplemental new drug application (sNDA) seeking label expansion for its ...