approval · primary record
NAXITAMAB-GQGK
FDA · BLA · 2025-08-27
| Agency | FDA |
|---|---|
| Submission type | BLA |
| Action date | 2025-08-27 |
| Brand | DANYELZA |
| Sponsor | Y-MABS THERAPEUTICS INC |
| Route | INTRAVENOUS |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-28T02:35:42.355Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: FDA:NAXITAMAB-GQGK:2025-08-27
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