US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter BLA 761393 (Mar 11, 2025)
Issued March 11, 2025
Issued
March 11, 2025
Application
BLA • 761393
Review center
CBER
Stage
Final Decision
Letter type
Complete Response Letter
Response due March 11, 2026Requires resubmission addressing deficiencies.
Document viewer
Read the FDA letter and send context to the co-pilot at any time.