12:00 AM
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...

Read the full 225 word article

User Sign in

Trial Subscription

Get a 4-week free trial subscription to BioCentury Week In Review

Article Purchase

$35 USD
More Info >