ARTMS Drug Master File for Gallium Production Technology Referenced with Telix’s Gozellix®
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 01 2025
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Source: Globenewswire
FDA Approval Announcement: Telix ARTMS, Inc. has received FDA approval for the drug master file (DMF) related to gallium-68 production using its QUANTM Irradiation System® (QIS®), marking a significant milestone in radiopharmaceuticals with the product Gozellix®.
Impact on Isotope Production: This approval will enhance the capacity for producing gallium-68, allowing for broader access in hospitals and radiopharmacies, while ARTMS continues to support the production of other important medical isotopes and expand its technology internationally.
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About TLX
Telix Pharmaceuticals Limited is an Australia-based biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. It is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Its segments include Therapeutics, Precision Medicine and Telix Manufacturing Solutions. Therapeutics segment develops targeted radionuclide therapies for urologic, neurologic, musculoskeletal and hematological cancers. Precision Medicine segment focuses on bringing diagnostic imaging solutions to market. Precision Medicine segment also includes MedTech and International businesses. Telix Manufacturing Solutions segment is its global network of facilities designed to deliver patient doses worldwide. Its pipeline products include TLX591, TLX250, TLX101, TLX66, TLX592, TLX252, TLX400, Illuccix (68Ga-PSMA-11) and TLX007-CDx.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
