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 ...
MPR

Dupixent Gets First FDA Approval for Allergic Fungal Rhinosinusitis

Dupixent (dupilumab) is now FDA-approved for adults and children aged 6 years and older with allergic fungal rhinosinusitis and prior sino-nasal surgery.
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 ...
Seeking Alpha

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) ...
Monthly Prescribing Reference

FDA Approval Allows for Use of Dupixent Prefilled Pens in Younger Patients

Dupixent single-dose prefilled pens feature a hidden needle and single-press auto-injection. The Food and Drug Administration (FDA) has expanded the approval of the Dupixent ® (dupilumab) single-dose ...

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 ...
Nasdaq

Dupixent® (dupilumab) Approved in China as the First-ever Biologic Medicine for Patients with Chronic Obstructive Pulmonary Disease (COPD)

Approval follows EU approval of Dupixent for adults with COPD with raised blood eosinophils, and is based on two landmark Phase 3 trials showing Dupixent significantly reduced exacerbations, improved ...
Seeking Alpha

Dupixent® (dupilumab) Approved in Japan for Children Aged 6 to 11 Years with Bronchial Asthma

Approval based on global Phase 3 program in children demonstrating Dupixent significantly reduced exacerbations (by 54% to 65%) and improved lung function (by 4.68% to 5.32%) compared to placebo ...
Healio

FDA approves expanded use of Dupixent pre-filled pens in young children

Please provide your email address to receive an email when new articles are posted on . The FDA has expanded approval of the single-dose Dupixent pre-filled pen for use in children aged as young as 2 ...