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Why Is FDA Taking Extra Time on Island Pharmaceuticals’ Galidesivir Review?

8:52am on Monday 5th of January, 2026 AEDT Pharmaceuticals
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Why Is FDA Taking Extra Time on Island Pharmaceuticals’ Galidesivir Review?

8:52am on Monday 5th of January, 2026 AEDT
Key Points
  • FDA confirms extended review period for Galidesivir clinical development
  • No adverse feedback or additional data requests from FDA
  • Galidesivir retains eligibility under Animal Rule and Priority Review Voucher
  • Preparations for non-human primate study and US government engagement continue
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