← FDA DRUG APPROVALS

FDA BLA · BLA761485

AVLAYAH

tividenofusp alfa-eknm

Sponsor: DENALI THERAPEUTICS INC.

APPLICATION
BLA761485
TYPE
BLA
ORIGINAL APPROVAL
2026-03-24
LATEST ACTION
2026-03-24
ROUTE
INTRAVENOUS, POWDER,FOR SOLUTION
DOSAGE FORM
INJECTION
MARKETING STATUS
Prescription

Products

AVLAYAHPrescription
TIVIDENOFUSP ALFA-EKNM 150MG/VIAL · INJECTION · POWDER,FOR SOLUTION

Approval history

2026-03-24Type 1 - New Molecular Entity · Original · priority — Label ↗AP
VIEW ON DRUGS@FDA ↗

Related on SPEQ

Biologics industry →GMP discipline →FDA drug shortages →FDA enforcement & recalls →

Source: FDA Drugs@FDA. SPEQ is not affiliated with the FDA; this is a reference view of public FDA data, not medical, legal, or regulatory advice.

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