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May 31, 2024
Recommendation for adults with uncontrolled COPD with raised blood eosinophils based on data from two landmark Phase 3 trials demonstrating Dupixent significantly reduced exacerbations and improved...
May 31, 2024
TARRYTOWN, N.Y. and PARIS, May 31, 2024 -- Regeneron Pharmaceuticals, Inc. and Sanofi today announced the U.S. Food and Drug Administration has extended by three months the target action date of...
May 20, 2024
NOTUS results confirm landmark data from the Phase 3 BOREAS trial and show Dupixent significantly reduced exacerbations by 34% and improved lung function, compared to placebo, in uncontrolled chronic...
February 23, 2024
Priority Review granted based on positive results from two Phase 3 trials; if approved, Dupixent would be the only biologic therapy for COPD and the first new treatment approach for this disease in...
February 16, 2024
Approval based on results from Phase 3 trial showing Dupixent significantly reduced itch compared to placebo CSU is the fifth approved indication for Dupixent in Japan and the sixth indication for...
January 25, 2024
Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo Expanded indication marks second disease for...
January 25, 2024
Approval based on Phase 3 EoE KIDS trial showing a greater proportion of children taking Dupixent achieved histological remission compared to placebo Expanded indication marks second disease for...
November 27, 2023
NOTUS trial met its primary endpoint with overwhelming efficacy, showing Dupixent significantly reduced exacerbations by 34% compared to placebo in patients with moderate-to-severe COPD with evidence...
October 22, 2023
Late-breaking presentation at ACG 2023 showed histologic and endoscopic improvements were maintained with no new safety signals to week 52 with higher dose Dupixent in these children Data reinforce...
October 20, 2023
TARRYTOWN, N.Y. and PARIS, Oct. 20, 2023 -- Regeneron Pharmaceuticals, Inc. and Sanofi today announced that the U.S. Food and Drug Administration has issued a Complete Response Letter for the...