Eosinophilic Cells Archives

FDA Accepts Dupixent® (dupilumab) for Priority Review in Patients Aged 12 Years and Older with Eosinophilic Esophagitis

Blockbusters, Eosinophilic Cells, Eosinophilic Esophagitis, Inflammatory Diseases, Regeneron Pharmaceuticals, Research & Development, Sanofi, Spplemental Biologics License Application (sBLA), Therapeutics

The U.S. Food and Drug Administration accepted for Priority Review the supplemental Biologics License Application for Dupixent (dupilumab) 300 mg weekly to treat adult and pediatric patients aged 12 years and older with eosinophilic esophagitis (EoE), a chronic and progressive type 2 inflammatory disease that damages the esophagus and impairs the ability to swallow.

Potential First-in-Class Asthma Treatment: Amgen and AstraZeneca’s Tezepelumab

Asthma, Business, Clinical Trials, Eosinophilic Cells, First-In-Class, Immune Response, Premarket Trading, Primary Endpoints, R&D, Shares

Amgen and AstraZeneca announced that their Phase III NAVIGATOR trial of the potential first-in-class human monoclonal antibody tezepelumab hit the primary endpoint in severe asthma.

FDA Approves Nucala as First Biologic Treatment for HES

Approvals, Biologics, Data, Eosinophilic Cells, Eosinophils, FDA/Regulatory, Hypereosinophilic Syndrome (HES), Rare Blood Disorders, White Blood Cells

The U.S. Food and Drug Administration approved GlaxoSmithKline plc’s Nucala (mepolizumab) for the treatment of adult and pediatric patients aged 12 years and older with Hypereosinophilic Syndrome (HES) for ≥ six months without an identifiable non-hematologic secondary cause.