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

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

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 ...

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

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 ...

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

In vitro tests have demonstrated that second-generation antihistamines have improved H 1-receptor specificity and a slower dissociation rate compared with first-generation antihistamines ...

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 ...

BOSTON -- Add-on dupilumab (Dupixent) significantly reduced itching and urticaria in patients with chronic spontaneous urticaria (CSU) whose symptoms were uncontrolled with H1-antihistamine therapy.

Histamine plays an important role in healthy immune functioning and neurotransmitter signaling. However, when these naturally ...

In November 2021, however, she came up against a case nearly impossible to solve. It all started when Elisha woke up with an ...