The FDA designates Bristol-Myers Squibb’s (NYSE:BMY) Orencia (abatacept) a Breakthrough Therapy for the prevention of moderate to severe acute graft-versus-host disease (GvHD) in hematopoietic stem cell transplants from unrelated donors.
Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.
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