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

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

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

Opens in a new tab or window If you're being treated for hives, your physician will want to hear what you think about your treatment ... can be used to assess chronic spontaneous urticaria ...

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

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

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 ...

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 ...

In May 2024, Novartis announced new data that confirm the long-term efficacy and safety of remibrutinib, a highly selective ...

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 ...