sanofi regeneron dupixent news

Dupixent, Regeneron

FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria

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

Business Insider · 14h

Regeneron, Sanofi announce FDA accepts Dupixent sBLA for review

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

Benzinga.com · 16h

FDA To Revisit Regeneron/Sanofi's Dupixent For Rare Skin Disease

Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a decision expected by April 2025.

MarketWatch · 17h

Regeneron, Sanofi Get New FDA Review of Dupixent for CSU

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 CSU, which causes sudden and debilitating hives and recurring itch.

Business Insider · 22h

Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous Urticaria

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

Benzinga.com2d

Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease

This expansion positions Dupixent as the first targeted therapy for COPD ... Further boosting the pipeline, mid-stage drugs ...

Managed Healthcare Executive13h

FDA Sets Date For Resubmitted Dupixent in Inflammatory Skin Disease

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

pharmaphorum1mon

Sanofi, Regeneron’s wager on Dupixent in COPD pays off

Sanofi and Regeneron acknowledged that testing their inflammatory disease blockbuster Dupixent in chronic obstructive pulmonary disease (COPD) was likely to be high-risk when they launched phase ...

Nasdaq9d

Regeneron, Sanofi announce EC approval for Dupixent

Regeneron (REGN) and Sanofi (SNY) announced that the European Commission, or EC, has approved Dupixent to treat eosinophilic esophagitis, or EoE, in children as young as one year of age.

Daily8d

Sanofi, Regeneron Dupixent approved in EU for young children with eosinophilic esophagitis

Paris: Sanofi has announced that the European Medicines Agency has approved Dupixent (dupilumab) to treat eosinophilic ...

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