Taiwan FDA OKs Heron Neutron Medical IND Application for Imaging Drug

MT Newswires Live

02/11

Heron Neutron Medical (TPE:7799) said Taiwan's Food and Drug Administration has in-principle approved its resubmitted investigational new drug (IND) application for F18 FBPA Injection, according to a Tuesday Taiwan Exchange filing.

Shares gained about 3% in Wednesday's late morning trade.

F18 FBPA is an imaging drug used in PET/CT scans to check tumors and test its safety and effectiveness.

The approval allows the company to proceed with Phase I and Phase II academic human clinical trials.

The IND was resubmitted on Dec. 8, 2025, and the company received notification of approval on Feb. 10, 2026.

Heron said no manufacturer worldwide has obtained regulatory approval for F18 FBPA, making the study a first-in-human trial.

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