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FDA Accepts Regeneron/Sanofi’s Dupixent® (Dupilumab) sBLA Resubmission for Chronic Spontaneous Urticaria
On 15 November 2024, Regeneron and Sanofi announced that the US FDA has accepted for review their resubmitted supplemental Biologics Licence Application (sBLA) for Dupixent® (dupilumab) for patients aged 12 years and older with chronic spontaneous urticaria (CSU)...