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.

Benzinga.com · 14h

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.

Business Insider · 12h

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

MarketWatch · 15h

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.

20h

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 ...

Managed Healthcare Executive11h

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 ...

Yahoo Finance2d

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

Also Read: Regeneron’s Dupixent COPD Sales To Reach $20B By 2026, Analyst Sees Larger Addressable Market The condition ...

Morningstar16d

Regeneron's Eye Disease Drug Eylea and Immunology Drug Dupixent Support a Narrow Moat

While Regeneron's Praluent has entered the multi-billion-dollar cholesterol-lowering market, it faces stiff competition from Amgen's Repatha and Novartis' Leqvio. Dupixent's potential could be cut ...

Investing2d

Regeneron Pharmaceuticals' SWOT analysis: stock faces biosimilar challenge, pipeline promise

In addition to the potential Eylea biosimilar from Amgen, Regeneron faces competition from products like Roche (LON:0QQ6)'s Vabysmo in the eye disease market. The company's diversification into ...

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