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

Urticaria is complicated to diagnose by its symptomatic overlap with other skin conditions and the frequent misclassification ...

The FDA made two de­ci­sions on Re­gen­eron’s best-sell­ing drugs Fri­day, hand­ing down one ap­proval and one re­jec­tion. The ap­proval came for Dupix­ent, the megablock­buster Re ...

“People with chronic spontaneous urticaria experience sudden, unpredictable hives and severe itch that cause a significant, and often overwhelming, burden on their everyday lives,” said Kenneth Mendez ...

Paris: Sanofi and Regeneron Pharma have received approval from the US Food and Drug Administration (FDA) for Dupixent (dupilumab) for the treatment of adults and adolescents aged 12 years and older ...

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 adults and adolescents aged 12 years and older ...

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 significantly reduced itch ...

The U.S. Food and Drug Administration (FDA) has approved Dupixent® (dupilumab) for treating adults and adolescents aged 12 and older with chronic spontaneous urticaria (CSU) who continue to ...

One came in 2023, however, when the FDA rejected it as a treatment for chronic spontaneous urticaria (CSU), asking for more data. Eighteen months later—and backed by more conclusive results ...

In the U.S., there are more than 300,000 adults and adolescents aged 12 years and older living with CSU who remain symptomatic despite antihistamine treatment TARRYTOWN, N.Y. and PARIS, April 18 ...