Telix Pharmaceuticals Limited (TLX.AX) said that the U.S. Food and Drug Administration has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit for the preparation of PSMA-PET imaging for prostate cancer. The Prescription Drug User Fee Act (PDUFA) goal date is March 24, 2025.
If approved, the new Kit will enable use of a PSMA imaging product with a considerably extended geographic distribution radius from a nuclear pharmacy compared to currently approved gallium-68 based agents, the company said.
PSMA-PET imaging represents a major advancement in prostate cancer management and in the U.S. has replaced conventional imaging methods (bone scan, CT scan) as the standard of care after initial diagnosis and biochemical recurrence.
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June 05, 2026 16:18 ET A busy week for economic news flow saw a slew of reports being released that reflected the trends in the U.S. labor market. In Europe, economic growth and inflation data gained attention as the European Central Bank and Bank of England head for policy session later in the month. In Asia, the monetary policy session of the Indian central bank was in focus as the country, a major oil importer, reels under the pressures of a weaker rupee and rising inflation.