FDA Rejects Dor Biopharma’s OrBec For GI Graft-Versus-Host Disease
This article was originally published in The Pink Sheet Daily
Executive Summary
In a “not approvable” letter, agency requests additional clinical trial data to show the drug is safe and effective.
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DOR BioPharma, meanwhile, has launched a Phase II trial of the oral beclomethasone dipropionate product in the prophylactic GVHD setting.