Medically reviewed by Jurairat J. Molina, MD Acute urticaria (hives) is a common skin condition that affects up to 20% of people at some point in their lives. It can transition into chronic urticaria ...

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

"Physicians face multiple challenges in the management of chronic spontaneous urticaria, including inconsistent measures of treatment success in clinical practice," wrote April Armstrong ...

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

1 While second-generation H1-antihistamines are standard therapy for both acute and chronic urticaria, some patients need additional treatment to find relief. A new study investigates whether ...

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

The FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...

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

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 ...