Zacks.com on MSN1h
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 ...
Contract Pharma2h
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 ...
Genentech gets FDA acceptance for its Lupus treatment's license application
Genentech, a Roche Group company(OTCQX:RHHBY) said on Wednesday that the U.S. FDA accepted the company’s supplemental ...
Lupus Foundation of America4h
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 ...
pharmaphorum4h
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 ...
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 respo ...
Le Lézard11h
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 Administration (FDA) has accepted the company's supplemental Biologics License ...