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FDA Greenlights Animal Rule Pathway, Boosting Island Pharmaceuticals’ Marburg Drug
9:35am on Monday 17th of November, 2025 AEDT
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Pharmaceuticals
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FDA Greenlights Animal Rule Pathway, Boosting Island Pharmaceuticals’ Marburg Drug
9:35am on Monday 17th of November, 2025 AEDT
Key Points
FDA endorses Animal Rule pathway for Galidesivir’s Marburg indication
Galidesivir qualifies for Priority Review Voucher valued up to US$155 million
Strong primate survival data (94%) supports regulatory approval strategy
Clinical trial design guidance received, enabling Q1 2026 trial commencement
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