Press Release: Sanofi and Regeneron’s Dupixent recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms despite treatment

Sanofi and Regeneron’s Dupixent recommended for EU approval to treat chronic spontaneous urticaria in young children with ongoing symptoms ...
Nasdaq

Regeneron : FDA Extends Review Period For Dupixent As COPD Treatment By Three Month

(RTTNews) - The U.S. Food and Drug Administration has extended by three months the target action date of its priority review of the supplemental Biologics License Application or sBLA for Dupixent ...
Yahoo Finance

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 ...
PharmExec

FDA Approves Dupixent as First Treatment for Allergic Fungal Rhinosinusitis in Adults and Children

The approval makes Dupixent the first FDA-approved therapy for allergic fungal rhinosinusitis, supported by Phase III data showing significant improvements in sinus opacification, nasal symptoms, and ...
Nasdaq

FDA accepts Dupixent® (dupilumab) for Priority Review in children aged 6 months to 5 years with moderate-to-severe atopic dermatitis

If approved, Dupixent will be the first biologic medicine available in the U.S. to treat uncontrolled moderate-to-severe atopic dermatitis for these young children Atopic dermatitis is a chronic type ...
Everyday Health

People With Severe Fungus Allergies Have a New Treatment Option

People with allergic fungal rhinosinusitis taking Dupixent (dupilumab) saw significant improvement in congestion and sinus ...
Seeking Alpha

Dupixent® (dupilumab) sBLA Accepted for FDA Review for the Treatment of Chronic Spontaneous Urticaria (CSU)

FDA decision expected by April 18, 2025; if approved, Dupixent would be the first targeted therapy for CSU in a decade Safety results in all LIBERTY-CUPID Phase 3 trials were generally consistent with ...
Seeking Alpha

Update on FDA Priority Review of Dupixent® (dupilumab) for the Treatment of COPD Patients with Type 2 Inflammation

TARRYTOWN, N.Y. and PARIS, May 31, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi today announced the U.S. Food and Drug Administration (FDA) has extended by three months ...
FiercePharma

Sanofi, Regeneron get a step closer on Dupixent COPD nod with FDA priority review

Regeneron and Sanofi have reached another milestone as they look to add to their megablockbuster immunology drug Dupixent a new U.S. indication for uncontrolled chronic obstructive pulmonary disease ...
Healio

FDA accepts sBLA, grants priority review for Dupixent to treat bullous pemphigoid

Please provide your email address to receive an email when new articles are posted on . If approved, Dupixent would be the first and only targeted medicine to treat bullous pemphigoid in the U.S. The ...
Morningstar

Regeneron, Sanofi Get Speedy FDA Review of Dupixent in Bullous Pemphigoid

Regeneron Pharmaceuticals and Sanofi have won Food and Drug Administration priority review of their application seeking expanded approval of their blockbuster anti-inflammatory drug Dupixent for ...

Dupixent® (dupilumab) Recommended for EU Approval to Treat Chronic Spontaneous Urticaria (CSU) in Young Children with Ongoing Symptoms Despite Treatment

If approved, Dupixent would be the first targeted medicine in the EU indicated for children aged 2 to 11 years with CSU inadequately controlled ...