FDA accepts Omblastys for priority review in pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.- Y-mAbs Therapeutics
Y-mAbs Therapeutics announced that the Biologics License Application for Omblastys (omburtamab) for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the FDA.
The FDA set an action date of November 30, 2022, under the Prescription Drug User Fee Act. The Agency also indicated in the BLA filing communication letter that it is planning to hold an advisory committee meeting in October 2022 to discuss the application.
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