The FDA has accepted Sanofi and Regeneron’s application to expand Dupixent’s use, with a decision expected by April 2025.
Regeneron and Sanofi's Dupixent sBLA for treating chronic spontaneous urticaria in patients 12+ gets FDA review, with a ...
The resubmitted sBLA will include results from Study C, which evaluated biologic-naive patients with uncontrolled CSU on antihistamines.
French drug major Sanofi (SNY) and Regeneron Pharmaceuticals, Inc. (REGN) announced Friday that the U.S. Food and Drug Administration ...
A major news story from Sanofi this month is that "The European Medicines Agency has approved Dupixent (dupilumab) to treat ...
Resubmission includes new pivotal data which confirm Dupixent significantly reduced itch and hive activityMore than 300,000 people in the U.S.
More than 1,000,000 patients are being treated with Dupixent globally. Dupilumab is being jointly developed by Sanofi and Regeneron under a global collaboration agreement. To date, dupilumab has been ...
The safety results from the EoE KIDS study were consistent with the known safety profile of Dupixent in adolescents and ...
Dupilumab significantly improves the day-to-day symptom burden in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).
The European Medicines Agency (EMA) approved Sanofi/Regeneron’s Dupixent (dupilumab) to treat eosinophilic esophagitis (EoE) in children as young as one. The approval extends the use of Dupixent ...
Dupixent significantly reduced itch and hive activity from baseline; 41% of patients achieved well-controlled disease status ...