U.S. Food and Drug Administration Accepts for Priority Review Bristol Myers Squibb’s Application for Orencia (abatacept) for the Prevention of Acute Graft Versus Host Disease

U.S. Food and Drug Administration assigned an action date of December 23, 2021
The sBLA is supported by the Phase 2 ABA2 Trial evaluating Orencia in adults and children to prevent aGvHD
If approved, Orencia would become the first therapy for the prevention of aGvHD
PRINCETON, N.J., August 23, 2021 –( BUSINESS WIRE )– Bristol Myers Squibb (NYSE:BMY) today announced that the U.S. Food and Drug Administration (FDA) has accepted its supplemental Biologics License Application (sBLA) for Orencia (abatacept) for the prevention of moderate to severe acute graft versus host disease (aGvHD) in patients 6 years of age …

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2021-08-23 10:59:00