FDA accepts supplemental Biologics License Application for Roche’s Gazyva/Gazyvaro for the treatment of lupus nephritis
Gazyva/Gazyvaro is the only anti-CD20 monoclonal antibody in a randomised phase III study to demonstrate a complete renal ...
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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 ...
The Pharma Letter3d
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 ...
Zacks Investment Research on MSN1d
Pharma Stock Roundup: BAYRY's Q4 Results, ABBV's Obesity Deal & More
Bayer BAYRY announced its fourth-quarter and full-year 2024 results. AbbVie ABBV announced a licensing deal with Danish firm ...
pharmaphorum3d
FDA starts review of Roche's Gazyva in lupus nephritis
The US regulator has started a review of Roche's supplemental biologics license application (BLA) for Gazyva/Gazyvaro ...
Genentech receives FDA acceptance for Gazyva sBLA
Genentech, a member of Roche (RHHBY), announced that the FDA has accepted the company’s supplemental biologics license application for Gazyva ...
Healio11d
Gazyva significantly boosts complete renal response rates in active lupus nephritis
Adding obinutuzumab to standard therapy for active lupus nephritis led to significantly higher rates of complete renal ...
FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY) announced today that the U.S. Food and Drug ...
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FDA Accepts Supplemental Biologics License Application for Gayzva for Treatment of Lupus Nephritis
The U.S. Food and Drug Administration (FDA) has accepted Genentech’s Supplemental Biologics License Application (sBLA) for ...
Pharmabiz3d
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 ...
Contract Pharma3d
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 ...
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FDA Accepts Supplemental Biologics License Application for Genentech’s Gazyva for the Treatment of Lupus Nephritis
Gazyva is the only anti-CD20 monoclonal antibody in a randomized Phase III study to demonstrate a complete renal response benefit – – The filing application is based on data from the Phase III ...