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# Priority Review Voucher Awarded to Y-mAbs Therapeutics
- URL: https://www.fdaweb.com/priority-review-voucher-awarded-to-y-mabs-therapeutics/
- Published: 2020-12-07T12:00:00.000Z
- Updated: 2026-09-14T16:39:13.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5148237

*Federal Register* notice: FDA has announced the issuance of a priority review voucher to Y-mAbs Therapeutics related to the approval of Danyelza (naxitamab-gqgk). The agency determined that the product met the criteria for a priority review voucher. It is indicated for use in combination with granulocyte-macrophage colony-stimulating factor for treating pediatric patients one 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. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2020-12-07/pdf/2020-26801.pdf?ref=fdaweb.com).