Expert Reaction: FDA Accepts Dupilumab sBLA for CSU
The U.S. Food and Drug Administration (FDA) recently accepted for review the resubmission of the supplemental Biologics License Application (sBLA) for dupilumab (Dupixent, Sanofi & Regeneron) to treat adults and pediatric patients aged 12 and up with chronic spontaneous urticaria (CSU) whose disease is not adequately controlled with H1 antihistamines. The new Prescription Drug User Fee […]