GSK

Trial and FDA signals

• FDA complete response letter Received an FDA complete response letter (BLA 761458, letter dated Dec 16, 2025). FDA BLA 761458 (Dec 16, 2025)
  Evidence (1 event)

  • Dec 16, 2025 · FDA BLA 761458
    CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE GlaxoSmithKline LLC Attention: David Colton Director, Global Regulatory Affairs Cambridge, MA (street omitted) Dear David Colton: Please refer to your biolog
• FDA complete response letter Received an FDA complete response letter (BLA 761440, letter dated Oct 23, 2025). FDA BLA 761440 (Oct 23, 2025)
  Evidence (1 event)

  • Oct 23, 2025 · FDA BLA 761440
    CRL text (OCR, redacted by FDA; first 200 chars from "COMPLETE RESPONSE"): COMPLETE RESPONSE GlaxoSmithKline LLC Attention: Hayley Karpick, PharmD, RPh Associate Director, Global Regulatory Affairs Collegeville, PA (street omitted) Dear Dr. Karpick

Job counts as of Oct 18, 2026. All trial and FDA signals