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Telix Pharmaceuticals Refiles NDA for Brain Cancer Imaging Candidate
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Telix Pharmaceuticals Refiles NDA for Brain Cancer Imaging Candidate
Mar 16, 2026 1:27 AM

03:44 AM EDT, 03/16/2026 (MT Newswires) -- Telix Pharmaceuticals ( TLX ) said late Sunday it resubmitted a new drug application for TLX101-Px, a positron emission tomography imaging agent, to the US Food and Drug Administration to track recurrent or progressive glioma from treatment-related changes in both adult and pediatric patients.

The company has refiled the new drug application with the additional data as per the regulator's request, it said.

Telix said the FDA has already granted orphan drug and fast track designations to TLX101-Px.

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