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) ...
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 ...
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 ...
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 ...
Approval in adults and children aged 6 years and older supported by Phase 3 trial demonstrating Dupixent significantly reduced nasal signs and ...
If approved, Dupixent would be the first targeted medicine in the EU indicated for children aged 2 to 11 years with CSU inadequately controlled ...
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 ...
Dupixent (dupilumab) is now FDA-approved for adults and children aged 6 years and older with allergic fungal rhinosinusitis and prior sino-nasal surgery.