Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria, or CSU, that is not adequately controlled with the current standard of care, H1 antihistamine treatment. The target action date for the FDA decision is October 22.
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