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How Island Pharmaceuticals Is Advancing Galidesivir Through FDA’s Animal Rule

8:36am on Thursday 4th of December, 2025 AEDT Pharmaceuticals
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How Island Pharmaceuticals Is Advancing Galidesivir Through FDA’s Animal Rule

8:36am on Thursday 4th of December, 2025 AEDT
Key Points
  • Submission of responses to FDA guidance on Galidesivir development
  • FDA confirmed eligibility for Animal Rule and Priority Review voucher
  • Pending FDA feedback expected by 2 January 2026
  • Plans to commence Marburg virus study in Q1 2026
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