Treats relapsed or refractory high-risk neuroblastoma in the bone or bone marrow. Sold as Danyelza. Every FDA application for this active ingredient.
As of Nov 15, 2026, FDA lists 1 application for Naxitamab-Gqgk (sold as Danyelza), first approved Nov 25, 2020, with 0 new uses approved and 0 published complete response letters.
| Approved | Application | Sponsor | Supplements | Marketing |
|---|---|---|---|---|
| Nov 25, 2020 | DanyelzaBLA 761171 · New molecular entity | Y-Mabs Therapeutics Inc | 2 | Marketed |
Applications, approvals and products come from FDA's Drugs@FDA data files, refreshed weekly, grouped by active ingredient as FDA spells it. Complete response letters are FDA's published letters. Medicare spending is CMS's Part D and Part B dashboard, matched to this ingredient by generic name; shortages are FDA's shortage list, matched by application number; clinical trials are ClinicalTrials.gov studies naming the ingredient as an intervention, refreshed daily; safety programs are FDA's REMS list, matched by application number or, for shared programs, by ingredient. Drugs@FDA
