Chronic spontaneous urticaria is an inflammatory skin disease that causes hives that last for at least six weeks. Derms ...
Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm ...
With unfortunately no curative therapy for chronic spontaneous urticaria (CSU) available for now, the overall goal is to ...
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.
The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
Urticaria may be acute or chronic. As opposed to acute urticaria, chronic urticaria is defined by recurrent episodes occurring at least twice a week for 6 weeks (Grattan, Sabroe, & Greaves ...
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 ...
While her research had quickly led her to believe that the itching and welts were hives, "I wasn't able to ... ethnic disparities in healthcare, and chronic conditions. Prior to joining PS ...