The label update is based on data from the late-stage LIBERTY-AD-HAFT study, which evaluated the efficacy and safety of Dupixent in 133 adult and adolescent (aged 12 to 17 years) patients with ...

The approval marks the sixth approved indication for Dupixent in the region and seventh globally. In the U.S., the FDA is expected to decide on a potential label expansion for Dupixent in COPD by ...

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

Dupixent (dupilumab) is a prescription drug that’s used to treat certain inflammatory conditions. The drug comes as a solution for injection under the skin. How often you’ll receive a dose ...

The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) in chronic ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity More than 300,000 people in the U.S. suffer from CSU that is inadequately controlled by ...