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.
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.
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)
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
EMA approves Sanofi/Regeneron’s Dupixent for young EoE patients
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and adults with EoE. Sanofi research and development head and e
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.
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.com5d
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 Executive2d
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 ...
Seeking Alpha5d
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 ...
Daily11d
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 ...