ILA secures Marburg data for its FDA approval pathway

Island Pharmaceuticals secured key natural history data for Marburg virus, enabling its US FDA Animal Rule pathway submission without costly new animal studies. This advance supports their New Drug Application and eligibility for a Priority Review Voucher, potentially accelerating regulatory approval for their drug Galidesivir against a high-fatality bioterrorism threat.

This Wire brief sits within Fusion42's coverage of Biotech.