Catalyst Biosciences, Inc. announced the U.S. Food and Drug Administration (FDA) has granted Rare Pediatric Disease Designation (RPDD) for CB 4332 for the treatment of Complement Factor I (CFI) deficiency (CFID). Under the FDA's rare pediatric disease designation program, the FDA may grant a priority review voucher to a sponsor who receives a product approval for a rare pediatric disease. A rare pediatric disease is defined as a serious or life-threatening condition that affects less than 200,000 individuals in the U.S. per year and who are primarily less than 18 years of age.
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- Catalyst Biosciences Receives Rare Pediatric Disease Designation for CB 4332 for the Treatment of CFI Deficiency