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FDA approves Dupixent as first biologic for children 2-11 with uncontrolled chronic spontaneous urticaria

Company Fundamentals
22 Apr 2026
GlobeNewsWire
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Bullish
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The FDA has approved Dupixent (dupilumab) for treating children aged 2 to 11 with chronic spontaneous urticaria (CSU) who do not respond to antihistamines. This marks the first biologic medicine approved in the U.S. for young children with uncontrolled CSU, a condition causing debilitating itch and hives. Approval is based on clinical trial data showing Dupixent's safety and efficacy in reducing symptoms. The drug is already approved for several other allergy-related conditions and is expected to improve quality of life for affected children.

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