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.
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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 ...
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 ...
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 ...
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 ...
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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GSK plc (GSK)
Regeneron Pharmaceuticals Inc (NASDAQ:REGN) and Sanofi SA’s (NASDAQ:SNY) Dupixent recently gained FDA approval for COPD, marking its sixth U.S. indication since its first use for atopic dermatitis ...
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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 ... Further boosting the pipeline, mid-stage drugs like ...
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Sanofi: Diverse Drug Portfolio And Future Pipeline, 4% Dividend Yield Looks Attractive
A major news story from Sanofi this month is that "The European Medicines Agency has approved Dupixent (dupilumab) to treat ...