The FDA is set to give its decision on SNY and REGN's sBLA for Dupixent for chronic spontaneous urticaria on April 18, 2025.

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

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

Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc ...

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

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

The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and ...

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 ...

Regeneron (REGN) and Sanofi (SNY) announced that the FDA has accepted for review the resubmission of the supplemental Biologics License Application, or sBLA, for Dupixent to treat adults and ...

Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the ...