← FDA Drug Approvals (Drugs@FDA)

AVLAYAH

BLA · Biologics License Application · Sponsor: DENALI THERAPEUTICS INC. · Approved 2026-03-24

Drug application

FDA Application #

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

Authoritative

Drugs@FDA application overview

Machine

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