FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent
By Dr. Matthew Watson
MELBOURNE, Australia, July 24, 2024 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has accepted the filing of its New Drug Application (NDA) for TLX007-CDx, a new and proprietary cold kit (“Kit”) for the preparation of PSMA-PET imaging1 for prostate cancer. The PDUFA2 goal date is March 24, 2025.
Originally posted here:
FDA Accepts Telix NDA for New Prostate Cancer Imaging Agent
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