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

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 FDA has provided a date of April 18, 2025, to review the application for Dupixent to treat patients with chronic ...

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 (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License ...

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

The FDA last year turned away the companies' application and asked for additional efficacy data. Regeneron and Sanofi said the resubmission adds results from an additional Phase 3 study of Dupixent in ...

Add-on oral antihistamines or montelukast (Singulair) do not add much benefit. In three separate trials, researchers randomized 3398 adolescent and adult patients with moderate-to-severe SAR ...

Celldex Therapeutics, Inc. (NASDAQ:CLDX) today reported financial results for the third quarter ended September 30, 2024 and provided a corporate update. "Celldex recently presented best-in-disease ...

It is further common practice to combine oral corticosteroids with antihistamines in the treatment ... most commonly used nonsedating histamine H 1-receptor blockers in South Africa) in a group ...