approval · primary record
NAXITAMAB-GQGK
FDA · BLA · 2025-08-27
| Agency | FDA |
|---|---|
| Submission type | BLA |
| Latest action | 2025-08-27 |
| Approval events | 1 |
| Brand | DANYELZA |
| Sponsor | Y-MABS THERAPEUTICS INC |
| Route | INTRAVENOUS |
Approval history
1 action on record. The drug is the stable record; each action below is an event with its own date, so this URL keeps working as new actions arrive.
| Date | Agency | Type | Brand | Sponsor | Route |
|---|---|---|---|---|---|
| 2025-08-27 | FDA | BLA | DANYELZA | Y-MABS THERAPEUTICS INC | INTRAVENOUS |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T06:31:52.548Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:naxitamab-gqgk
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Naxitamab-Gqgk · compound