Pulmonology Advisor

Dupixent Gets First FDA Approval for Allergic Fungal Rhinosinusitis

The FDA has approved Dupixent (dupilumab) for the treatment of adult and pediatric patients aged 6 years and older with allergic fungal rhinosinusitis.
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Dupixent® (dupilumab injection) approved in Canada for adults with inadequately controlled Chronic Obstructive Pulmonary Disease (COPD)

TORONTO, Oct. 22, 2025 /CNW/ - Health Canada has approved Dupixent® (dupilumab injection) as an add-on maintenance treatment in adult patients with chronic obstructive pulmonary disease (COPD) ...

Dupixent® (dupilumab) Approved in the U.S. as the First and Only Medicine for Allergic Fungal Rhinosinusitis (AFRS)

Approval in adults and children aged 6 years and older supported by Phase 3 trial demonstrating Dupixent significantly reduced nasal signs and ...
Seeking Alpha

Dupixent® (dupilumab) Approved in the U.S. as the First New Targeted Therapy in Over a Decade for Chronic Spontaneous Urticaria (CSU)

TARRYTOWN, N.Y. and PARIS, April 18, 2025 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved Dupixent ® ...
Nasdaq

Dupixent® (dupilumab) Approved in the U.S. as First and Only Treatment for Adolescents with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)

TARRYTOWN, N.Y. and PARIS, Sept. 13, 2024 (GLOBE NEWSWIRE) -- Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) and Sanofi today announced that the U.S. Food and Drug Administration (FDA) has approved ...
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 ...
PharmiWeb

Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitis

Sanofi and Regeneron’s Dupixent approved in the US as the first and only medicine for allergic fungal rhinosinusitisApproval in adults and children aged 6 years and older supported by phase 3 study ...
Reuters

EU approves Sanofi's Dupixent for 'smoker's lungs'

July 3 (Reuters) - Sanofi (SASY.PA), opens new tab and partner Regeneron (REGN.O), opens new tab on Wednesday won European Union approval for wider use of their Dupixent injection in patients with a ...
Nasdaq

Press Release: Dupixent approved in the EU as the first-ever targeted therapy for patients with COPD

First-in-world approval of Dupixent for adults with uncontrolled COPD with raised blood eosinophils based on two landmark phase 3 studies showing Dupixent significantly reduced exacerbations, improved ...

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 ...
CNN

Regeneron Collaborations on Dupixent® (dupilumab) Highlighted During Sanofi R&D Investor Event

Dupixent meets early efficacy threshold for continuation in ongoing Phase 3 trial of patients with COPD; second confirmatory trial will commence in third quarter of 2020 Regeneron Pharmaceuticals, Inc ...
Medical News Today

Dupixent: Your Reddit questions answered

However, as with any major medical treatment, the transition from clinical trials to the “real world” often leads to questions that aren’t always covered in a standard doctor’s visit. Patients are ...