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 ...

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

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

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 ...

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

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

Regeneron Pharmaceuticals and Sanofi said the U.S. Food and Drug Administration has accepted their resubmitted application seeking expanded approval of the blockbuster anti-inflammatory drug ...

Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc NASDAQ: AMGN/AstraZeneca’s tezepelumab, and GSK’s mepolizumab are ...

The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) in chronic ...