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

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

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 ...

With unfortunately no curative therapy for chronic spontaneous urticaria (CSU) available for now, the overall goal is to ...

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

In May 2024, Novartis announced new ... the treatment of CIndU. In February 2024, ARS Pharmaceuticals announced positive efficacy results in its phase II inpatient chronic spontaneous urticaria ...

1 While second-generation H1-antihistamines are standard therapy for both acute and chronic urticaria, some patients need additional treatment to find relief. A new study investigates whether ...

Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.

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

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 ...

and others are evaluating new urticaria drugs to improve the treatment landscape. Promising pipeline urticaria therapies such as Dupilumab, TAS5315, AK006, YH35324, UB-221, TLL-018, KPL-716, AK002, ...