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Regeneron And Sanofi Snag Their $6 Billion-Potential COPD Approval For Dupixent
Regeneron announced Friday that the company won Food and Drug Administration approval for Dupixent in chronic obstructive ...
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FDA to review Sanofi's Dupixent in asthma
This makes the new indication for Dupixent very important for Sanofi as it searches for a blockbuster to transform its fortunes. The FDA is set to make a decision on Dupixent’s new indication on ...
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FDA reviews Sanofi and Regeneron’s Dupixent label expansion for urticaria
The US Food and Drug Administration (FDA) has accepted for review the resubmitted supplemental Biologics License Application (sBLA) for Sanofi and Regeneron’s Dupixent (dupilumab) in chronic ...
Business Insider3d
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 Application, or sBLA, for Dupixent to treat adults and ...
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Dupixent delivers in two skin disease trials
Sanofi and Regeneron have celebrated a pair of positive clinical trials in inflammatory skin disorders with blockbuster immunology therapy Dupixent that could both lead to new indications for the ...
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Dupixent® (dupilumab) Approved in the European Union as the First and Only Medicine for Young Children with Eosinophilic Esophagitis
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to ...
Morningstar3d
Regeneron, Sanofi Get New FDA Review of Dupixent for CSU
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. The companies said an ...
FDA Approves Dupixent Injections For People Struggling With COPD Symptoms
The U.S. Food and Drug Administration (FDA) has approved Dupixent (dupilumab) injections as an add-on therapy for adults with ...
Business Insider3d
Sanofi, Regeneron's Dupixent SBLA Accepted For FDA Review To Treat Chronic Spontaneous Urticaria
The FDA decision is expected by April 18, 2025. If approved, Dupixent would be the first targeted therapy for CSU in a decade. The sBLA for Dupixent (dupilumab) is to treat adults and pediatric ...
Morningstar12d
Press Release: Dupixent approved in the EU as the first and only medicine for young children with eosinophilic esophagitis
Approval based on phase 3 data showing significantly more children aged one to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up ...
Yahoo Finance12d
Dupixent® (dupilumab) Approved in the European Union as the First and Only Medicine for Young Children with Eosinophilic Esophagitis
Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on Dupixent achieved histological disease remission at 16 weeks compared to placebo, which was sustained up to one ...