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 activityMore ...

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

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 ...

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

French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...

It can transition into chronic urticaria for up to 8% of the population. Hives tend to go away without treatment, but self-care strategies like taking a cooling bath can help manage discomfort. Some ...

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

Novartis is just months away from filing for approval of oral BTK inhibitor remibrutinib as a treatment for chronic spontaneous urticaria – also known as chronic hives – after reporting long ...

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 ...

Revenue: Total revenue was $2.1 million for the quarter ended September 30, 2024, comprised of $0.6 million in net product ...