approval · primary record
GARADACIMAB-GXII
FDA · BLA · 2025-06-16
| Agency | FDA |
|---|---|
| Submission type | BLA |
| Latest action | 2025-06-16 |
| Approval events | 1 |
| Brand | ANDEMBRY |
| Sponsor | CSL BEHRING LLC |
| Route | SUBCUTANEOUS |
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 |
|---|---|---|---|---|---|
| 2025-06-16 | FDA | BLA | ANDEMBRY | CSL BEHRING LLC | SUBCUTANEOUS |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T00:31:23.787Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:garadacimab-gxii
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Garadacimab-Gxii · compound