Y-mAbs Announces Complete Response Letter for Omburtamab Biologics License Application

Posted: December 2, 2022 at 12:43 am

NEW YORK, Dec. 01, 2022 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. Food and Drug Administration (“FDA”) has issued a complete response letter (“CRL”) for the Biologics License Application (“BLA”) for the investigational medicine 131I-omburtamab (“omburtamab”) for the treatment of CNS/leptomeningeal metastasis from neuroblastoma.

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Y-mAbs Announces Complete Response Letter for Omburtamab Biologics License Application

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