Lyfgenia

Genetix Biotherapeutics Inc.🇺🇸 United States

FDA Page

Effective Date: Jul 21, 2026
Approval ID: 0d1b475e-5781-2bd1-e063-6294a90a7311
Products: 1 registered
Version: 8

Regulatory Information

Labeling Type

CELLULAR THERAPY

Status

Approved

Full Title

These highlights do not include all the information needed to use LYFGENIA safely and effectively. See full prescribing information for LYFGENIA. LYFGENIA® (lovotibeglogene autotemcel) suspension for intravenous infusion Initial U.S. Approval: 2023

Quick Stats

Total Products1

Labelers2

Label Sections40

Regulatory Agency

🇺🇸

U.S. Food and Drug Administration

United States

Data Sources & Disclaimer: Approval information is sourced from official FDA databases. This content is for informational purposes only and does not constitute medical or regulatory advice. Always refer to official FDA websites for the most current information.