Danyelza FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 27, 2021.
FDA Approved: Yes (First approved November 25, 2020)
Brand name: Danyelza
Generic name: naxitamab-gqgk
Dosage form: Injection
Company: Y-mAbs Therapeutics, Inc.
Treatment for: Neuroblastoma
Danyelza (naxitamab-gqgk) is a GD2-binding monoclonal antibody indicated, in combination with granulocyte-macrophage colony-stimulating factor (GMCSF), for the treatment of patients with relapsed or refractory high-risk neuroblastoma.
Development Timeline for Danyelza
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