Posted by Michael Wonder on 02 Jun 2020
Y-mAbs announces U.S. FDA acceptance of biologics license application for Danyelza (naxitamab) for the treatment of neuroblastoma for priority review
2 June 2020 - Y-mAbs Therapeutics today announced that the biologics license application for Danyelza (naxitamab) for the treatment of patients with relapsed/refractory high-risk neuroblastoma has been accepted for priority review by the U.S. FDA.
The FDA set an action date of November 30, 2020, under the Prescription Drug User Fee Act.
The Agency also indicated in the BLA filing communication letter that it is not currently planning to hold an advisory committee meeting to discuss the application.
