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Danyelza® (naxitamab-gqgk) – New orphan drug approval

November 25, 2020, Y-mAbs Therapeutics announced the FDA approval of Danyelza (naxitamab-gqgk), in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.

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