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

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 ...

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 ...

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

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 ...

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

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 ...

Background: Chronic idiopathic urticaria is a distressing condition ... the health economic impact of daily levocetirizine treatment in adults with CIU. This is the first paper to address this ...

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