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FDA Greenlights Galidesivir’s Animal Rule Pathway, Paving Way for Accelerated Approval
9:40am on Wednesday 4th of February, 2026 AEDT
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Pharmaceuticals
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FDA Greenlights Galidesivir’s Animal Rule Pathway, Paving Way for Accelerated Approval
9:40am on Wednesday 4th of February, 2026 AEDT
Key Points
FDA validates Island’s Marburg virus animal model for Galidesivir
Two-stage clinical development pathway established, reducing regulatory risk
Dose optimisation and pharmacokinetic studies to start imminently
Galidesivir eligible for a Priority Review Voucher valued around US$200 million
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