Dupixent, Regeneron and FDA

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'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
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.
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 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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Regeneron/Sanofi's Dupixent Approval Signals Major Treatment Breakthrough For Smokers' Lung Disease
Further boosting the pipeline, mid-stage drugs like Sanofi/Regeneron’s itepekimab, AstraZeneca’s benralizumab, Amgen Inc ...
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Sanofi sheds Regeneron stake, but insists collaboration is unaffected
Earlier in 2019 Sanofi also paid Regeneron $462 million to exit from an immuno-oncology alliance formed in 2015, and in 2017 said they would end discovery research in new antibody drugs.
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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 ...