Y-mAbs submits omburtamab marketing authorisation application to the EMA

Y-mAbs

27 April 2021 - Y-mAbs Therapeutics today announced that the Company has submitted its marketing authorisation application to the European Medicines Agency for omburtamab for the treatment of paediatric patients with CNS/leptomeningeal metastasis from neuroblastoma.

In addition, Y-mAbs recently concluded a Type B meeting with the U.S. FDA regarding omburtamab and the Company continues to be in close dialog with the FDA and maintains its aim of resubmitting the biologics license application to the FDA late in the second quarter or in the third quarter of 2021.

Read Y-mAbs press release

Michael Wonder

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Michael Wonder

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Cancer , Medicine , Europe , Dossier