The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for chronic spontaneous urticaria on April 18, 2025.

INCY stops enrollment in the phase II study of MRGPRX2 in CSU after making certain in vivo preclinical toxicology discoveries.

to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target ...

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 ...

CSU is a chronic inflammatory skin disease driven in part by type 2 inflammation, which causes sudden and debilitating hives and recurring itch. CSU is typically treated with H1 antihistamines, ...

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 ...

Dupixent sBLA accepted for FDA review for the treatment of chronic spontaneous urticaria Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activity ...

for the treatment of chronic spontaneous urticaria (CSU) in adults and pediatric patients aged 12 years and older inadequately controlled with H1 antihistamine treatment. The original sBLA was ...

to treat adults and pediatric patients aged 12 years and older with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamine treatment. The target ...

Another term for CSU is chronic idiopathic urticaria (CIU). Chronic hives last for more than six weeks. Ligelizumab is in development at the Swiss multinational drug company, Novartis Pharmaceuticals, ...

Novartis’ immunoglobulin E inhibitor Xolair has been a mainstay of treatment for chronic spontaneous urticaria (CSU) for many years, but the company says it has gone one better with new ...