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FDA Has Lifted The Clinical Hold On GH Research's Investigational New Drug Application For GH001, Phase 3 Initiation Targeted For 2026

Benzinga Newsdesk 10 months ago

NewsHealth CareFDAGeneral

GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollmentCompany to seek FDA alignment on global Phase 3 program replicating Phase 2b designPhase 3 initiation targeted for 2026

  • GH001 cleared by FDA for U.S. clinical investigation, enabling U.S. subject enrollment
  • Company to seek FDA alignment on global Phase 3 program replicating Phase 2b design
  • Phase 3 initiation targeted for 2026

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