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Apr 29, 2013
 |  BC Week In Review  |  Clinical News  |  Regulatory

Defitelio defibrotide regulatory update

As expected, Gentium requested a re-examination of a negative opinion from EMA's CHMP recommending against approval of an MAA for Defitelio defibrotide to treat and prevent hepatic veno-occlusive disease (VOD) in adults and children undergoing hematopoietic stem cell transplantation therapy. In its negative opinion last month, CHMP said data...

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