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FDA Grants Dupixent Breakthrough Therapy Designation for Eosinophilic Esophagitis
September 18, 2020Regeneron Pharmaceuticals and Sanofi announced the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation to Dupixent® (dupilumab) for the treatment of patients 12 years and older with eosinophilic esophagitis (EoE). -
Dupixent Eosinophilic Esophagitis Trial Meets Both Co-Primary Endpoints
June 01, 2020Regeneron Pharmaceuticals and Sanofi announced positive results from Part A of the pivotal Phase 3 trial evaluating Dupixent® (dupilumab) in patients 12 years and older with eosinophilic esophagitis (EoE). -
Fasenra Granted Orphan Drug Designation
September 03, 2019AstraZeneca announced the US Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to Fasenra (benralizumab) for the treatment of eosinophilic oesophagitis (EoE).
Pharma Sources Insight January 2025
