31 May 2022 - Y-mAbs Therapeutics today announced that the biologics license application for Omblasyts (omburtamab) for the treatment of paediatric patients with CNS/leptomeningeal metastasis from neuroblastoma has been accepted for priority review by the U.S. FDA.
The FDA set an action date of 30 November 2022, under the Prescription Drug User Fee Act.