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Although systemic etanercept was approved in 2004 for adults, the Food and Drug Administration (FDA) denied approval for use in children with psoriasis in 2008. Revision of the FDA's risk‐benefit assessment in response to understanding of disease burden, unmet medical need, and the effect of off‐label use in children with psoriasis led to the 2016 approval as the first systemic biologic product for...
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