US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter BLA 125842 (Jul 9, 2025)
Issued July 9, 2025
Issued
July 9, 2025
Application
BLA • 125842
Review center
CBER
Stage
Final Decision
Letter type
Complete Response Letter
Response due July 9, 2026Requires resubmission addressing deficiencies.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.