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Chronic Spontaneous Urticaria HealthcareRegulationFederal Checked 8/9/2026 Source Active

"CSU Treatment Expansion"

FDA Approval of Dupilumab for Chronic Spontaneous Urticaria

Federal 21 CFR Part 201 2025

Transparency & Verification

Verified from Official Source
Source AgencyFood and Drug Administration (FDA)
Last Updated2026-07-10
Last Verified2026-08-09
Verified ByPolicyPantry Editorial Team
Last checked: 2026-08-09 approved

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Summary

Expands the indication of dupilumab to include the treatment of chronic spontaneous urticaria (CSU) in patients 12 years and older uncontrolled by antihistamines.

Who This Bill Serves & Who's Backing It

Core Patient Populations

[object Object] Chronic Spontaneous Urticaria

People with chronic spontaneous urticaria (hives).

Advocacy Groups Backing This Legislation

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Legislative Timeline

Votes & Legislative History

Legislative History & Resources

Legislative HistoryApproved Apr 18, 2025

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