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.
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 ...
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 ...
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/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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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 ...
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EU regulators endorse meds from BMS, J&J, Eisai and more—plus a clutch of biosims
Now, it's up to the European Commission to confirm those potential green lights in the coming weeks and months.
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Novel SOURCE study examining development of early COPD in ages 30 to 55
Researchers are exploring how small airway abnormalities in younger smokers could help identify who is at risk of developing COPD and establish how the chronic lung disease progresses.
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A Pharma Brand Dominates At Spot TV
An eczema drug jointly developed by pharmaceutical companies Regeneron and Sanofi continues to stand above all comers when it ...
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BMS, Merck, Amgen and more must look to M&A to offset looming patent lapses: Leerink
As a wave of patent expirations encroaches upon many of the world’s top drugmakers, companies will need to be diligent in ...
Non-Cystic Fibrosis Bronchiectasis Pipeline Insight: Over 15 Companies are Progressing Through to Improve the Treatment Landscape | DelveInsight
The non-cystic fibrosis bronchiectasis market is driven by rising prevalence linked to respiratory infections, autoimmune diseases, and COPD. Increasing awareness among healthcare providers and ...