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Dupixent, Regeneron and FDA

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 · 19h

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 · 22h

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.

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Sanofi plans to boost stake in Regeneron

Sanofi has announced its plans to buy more shares in US biotech, Regeneron Pharmaceuticals. The French drugmaker currently controls approximately 17% of Regeneron. Due to a long-term partnership ...

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 ...

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Regeneron (REGN), Sanofi's Dupixent Gets Label Update in US

Regeneron Pharmaceuticals, Inc. REGN and partner Sanofi SNY announced that the FDA has updated the label for Dupixent (dupilumab) for the indication of atopic dermatitis. Per the latest FDA update ...

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Dupixent, Regeneron and FDA

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