The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...

Chronic spontaneous urticaria is an inflammatory skin disease that causes hives that last for at least six weeks. Derms ...

With unfortunately no curative therapy for chronic spontaneous urticaria (CSU) available for now, the overall goal is to ...

The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.

If you have chronic hives, which means they linger for at least six weeks, you may be prescribed medications, including anti-inflammatory drugs, drugs that suppress the immune system, and drugs ...

In November 2021, however, she came up against a case nearly impossible to solve. It all started when Elisha woke up with an ...

Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...

The US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA) for Dupixent (dupilumab) to treat adults and pediatric ...