US FDA•United StatesCRL•Complete Response Letter
Complete Response Letter BLA 761303 (Jul 30, 2025)
Issued July 30, 2025
Issued
July 30, 2025
Application
BLA • 761303
Review center
CBER
Stage
Final Decision
Letter type
Complete Response Letter
Response due July 30, 2026Requires resubmission addressing deficiencies.
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