approval · primary record
DARATUMUMAB AND HYALURONIDASE-FIHJ
FDA · BLA · 2026-02-12
| Agency | FDA |
|---|---|
| Submission type | BLA |
| Latest action | 2026-02-12 |
| Approval events | 1 |
| Brand | DARZALEX FASPRO |
| Sponsor | JANSSEN BIOTECH |
| Route | INJECTION |
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 |
|---|---|---|---|---|---|
| 2026-02-12 | FDA | BLA | DARZALEX FASPRO | JANSSEN BIOTECH | INJECTION |
Provenance
- Source: openFDA Drugs@FDA
- Fetched at: 2026-10-30T06:32:00.601Z
- Licence class: public-domain
- Verdict: primary-source
- Entity id: approval:daratumumab-and-hyaluronidase-fihj
This record is rendered from the AEaH spine. If the source is unreachable the page is not generated.
Same entity, elsewhere in the suite
- Daratumumab And Hyaluronidase-Fihj · compound