The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
GlobalData on MSN23h
FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticariaThe FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
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