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Dupixent, Regeneron and FDA

GlobalData on MSN · 3d

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 · 4d

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 · 4d

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 · 4d

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

Sanofi, Regeneron Dupixent sBLA accepted for USFDA review for chronic spontaneous urticaria

Paris: Sanofi and Regeneron has announced that the US Food and Drug Administration (FDA) has accepted for review the resubmission of the supplemental biologics license application (sBLA)

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FDA Accepts SNY and REGN's Dupixent Re-Submitted sBLA for Urticaria

Sanofi SNY and partner Regeneron REGN announced that the FDA has accepted their resubmitted supplemental biologics ...

FDA Considers New Dupilumab Data for Chronic Spontaneous Urticaria Indication

The US Food and Drug Administration (FDA) has accepted a resubmission of the supplemental Biologics License Application for ...

3d

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 ...

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