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FDA Approval Sought for Naxitamab in Neuroblastoma

Jason M. Broderick @jasoncology
Published: Saturday, Apr 04, 2020

Y-mAbs Therapeutics, Inc., has completed submission of a Biologics License Application (BLA) to the FDA for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma.1

Commenting on the BLA submission, Claus Moller, MD, PhD, chief executive officer of Y-mAbs, said in the press release, “With this submission, we look forward to working with the [FDA] to bring naxitamab to appropriate patients. We are excited to complete this submission and believe naxitamab can address a significant unmet medical need for children with relapsed/refractory high-risk neuroblastoma.”

References           

  1. Y-mAbs Announces Submission of Naxitamab Biologics License Application to U.S. FDA. Published April 1, 2020. https://bit.ly/2R74fLy. Accessed April 4, 2020.
  2. Y-mAbs Announces Naxitamab Update. Published October 25, 2019. https://bit.ly/2V3exNU. Accessed April 4, 2020.
  3. Y-mAbs Receives Breakthrough Therapy Designation for Naxitamab for the treatment of High Risk Neuroblastoma. Published August 21, 2018. https://bit.ly/2UWURv8. Accessed April 4, 2020.

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