Priority Review and Orphan Drug Designations

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FDA granted Priority Review for defibrotide for the treatment of patients with hepatic veno-occlusive disease, also known as sinusoidal obstruction syndrome, with evidence of multi-organ dysfunction following hematopoietic stem-cell transplantation. FDA review of the new drug application is expected to be completed by March 31, 2016. The application, submitted by Jazz Pharmaceuticals plc, includes safety...

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