Dupixent, which was rejected by the FDA for chronic spontaneous urticaria in October 2023, is now approved as the first new targeted therapy for the indication in more than 10 years.

WEDNESDAY, April 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria.

In pooled data from all three studies, the most common adverse event (≥2%) more frequently observed in patients on Dupixent compared to placebo was injection site reactions.

It was also demonstrated that Dupixent, a monoclonal antibody that is administered via injection, also significantly improved lung function and asthma control in patients with co-morbid asthma.

Regeneron Pharmaceuticals (REGN) and Sanofi (SNY) announced that the U.S. Food and Drug Administration has approved Dupixent for the treatment of adults and adolescents aged 12 years and older ...

Dupixent approved as the first-ever biologic medicine in Japan for patients with COPD Following recent approvals in the EU, China, and the US, this approval was based on pivotal phase 3 results in ...

WEDNESDAY, April 23, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria.

In pooled data from all three studies, the most common adverse event (≥2%) more frequently observed in patients on Dupixent compared to placebo was injection site reactions. George D. Yancopoulus, M.D ...

The U.S. Food and Drug Administration has approved Dupixent (dupilumab) for the treatment of adults and adolescents with chronic spontaneous urticaria. The approval is for patients 12 years and ...