The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with ...

Living with Chronic Spontaneous Urticaria can be challenging, especially when triggers seem ubiquitous. Here's what you need ...

The FDA has approved Dupixent for the treatment of patients aged 12 years and older with CSU who remain symptomatic despite H1 antihistamine treatment.

The U.S. FDA issued a complete response letter in October 2023 for Dupixent (dupilumab) in treating chronic hives but has now approved the monoclonal antibody for the indication. The approval makes ...

Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new ...

The FDA made two de­ci­sions on Re­gen­eron’s best-sell­ing drugs Fri­day, hand­ing down one ap­proval and one re­jec­tion.

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

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

The partners overcame an earlier rejection to win a seventh use for Dupixent, though some analysts are skeptical of its sales ...

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

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

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