Resubmission of the supplemental biologics license application provided more data on improvement in hives and itching in ...

The FDA approved dupilumab for the treatment of patients 12 years and older with chronic spontaneous urticaria who remain ...

The FDA approved dupilumab (Dupixent) for chronic spontaneous urticaria (CSU) in patients 12 years and older, the first new ...

Approval based on Phase 3 trials demonstrating Dupixent significantly reduced itch and hives compared to placebo In the U.S., there are more than ...

Marking the first approval in over a decade for this challenging condition, the FDA has approved dupilumab (Dupixent) to treat chronic spontaneous urticaria in patients 12 years and older whose hives ...

Paris: Sanofi has received approval from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) for the treatment ...

PARIS, France and TARRYTOWN, NY, USA I April 18, 2025 I The US Food and Drug Administration (FDA) has approved Dupixent (dupilumab) for the treatment of ...

The CSU indication is the seventh disease driven in part by underlying type 2 inflammation in which Dupixent has received approval.

Dupixent approved in the US as the first new targeted therapy in over a decade for chronic spontaneous urticaria . Approval based on phase 3 studies demonstrating Dupixent signifi ...

Chronic spontaneous urticaria is chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden ...

Dupixent is the first new targeted therapy to receive FDA-approval for chronic spontaneous urticaria in adults and ...