Latest Fda Animal Rule News

Island Pharmaceuticals has inked a Master Service Agreement with Texas Biomedical Research Institute, enhancing its strategic position to advance Galidesivir through the FDA Animal Rule pathway. This partnership aligns with US government priorities on viral threats and sets the stage for a planned clinical program in early 2026.

Island Pharmaceuticals has been granted a pivotal US patent extending protection for its antiviral drug Galidesivir as a Covid-19 treatment until 2042, reinforcing its strategic position in the antiviral market.

Island Pharmaceuticals has submitted critical responses to the FDA, advancing the development of its antiviral Galidesivir under the Animal Rule pathway. The company awaits FDA feedback expected by early January 2026, setting the stage for upcoming Marburg virus studies.

Island Pharmaceuticals has secured over $1 million through option exercises by directors and major shareholders, bolstering its cash reserves to advance the clinical and regulatory development of its broad-spectrum antiviral, Galidesivir.

Island Pharmaceuticals has engaged a top Washington DC government affairs firm to accelerate its US biodefence strategy, focusing on its antiviral drug Galidesivir amid promising FDA regulatory signals.

Island Pharmaceuticals will host a webinar to discuss the FDA's feedback on the clinical development and regulatory approval of its antiviral drug Galidesivir, including key considerations under the FDA's Animal Rule and Priority Review Voucher eligibility.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir and is progressing regulatory discussions with the FDA to fast-track approval using the Animal Rule, backed by compelling preclinical data.

Island Pharmaceuticals secures FDA confirmation that regulatory feedback on Galidesivir’s approval pathway will arrive on schedule, underscoring the drug’s strategic importance amid US government disruptions.

Island Pharmaceuticals has completed its acquisition of the broad-spectrum antiviral Galidesivir ahead of schedule, setting sights on expedited FDA approval leveraging the Animal Rule.

Island Pharmaceuticals reported promising Phase 2a/b trial results for its dengue drug ISLA-101 and secured a strategic acquisition of the broad-spectrum antiviral Galidesivir, bolstering its pipeline and balance sheet.

Island Pharmaceuticals has accelerated its acquisition of the Galidesivir antiviral program from BioCryst Pharmaceuticals, adding a clinically advanced asset with significant US government backing and a promising regulatory pathway.