# AVLAYAH
> **BLA761485** · Biologics License Application · Sponsor: DENALI THERAPEUTICS INC. · Approved 2026-03-24
## Drug
- **FDA Application Number:** BLA761485
- **Application type:** Biologics License Application
- **Brand name:** AVLAYAH
- **Generic name:** TIVIDENOFUSP ALFA-EKNM
- **Active ingredients:** TIVIDENOFUSP ALFA-EKNM
- **Dosage form:** INJECTION
- **Route:** POWDER,FOR SOLUTION
- **Marketing status:** Prescription
- **Sponsor:** DENALI THERAPEUTICS INC.
- **Manufacturer:** Denali Therapeutics Inc.
- **First approval:** 2026-03-24
## Source
- [Drugs@FDA application overview](https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761485)
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