FDA Approves New Prostate Cancer Imaging Agent Gozellix®
Telix Pharmaceuticals Limited - American Depositary Shares (TLX)
Company Research
Source: GlobeNewswire
MELBOURNE, Australia and INDIANAPOLIS, March 21, 2025 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United States (U.S.) Food and Drug Administration (FDA) has approved its New Drug Application (NDA) for Gozellix® (TLX007-CDx, kit for the preparation of gallium-68 (68Ga) gozetotide injection), Telix’s next-generation PSMA-PET imaging1 agent for prostate cancer. Gozellix®, after radiolabeling with 68Ga, is indicated for PET scanning of PSMA positive lesions in men with prostate cancer who have suspected metastasis and are candidates for initial definitive therapy, and those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) lev
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TLX
News
- FDA Approves New Prostate Cancer Imaging Agent Gozellix®PR Newswire
- Illuccix® PSMA-PET-beeldvormingsagens voor prostaatkanker goedgekeurd in NederlandPR Newswire
- Illuccix® Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin AmericaPR Newswire
- Illuccix® Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin AmericaPR Newswire
- Illuccix® Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin AmericaGlobeNewswire
TLX
Sec Filings
- 3/21/25 - Form 6-K
- 3/18/25 - Form 6-K
- 3/12/25 - Form 6-K
- TLX's page on the SEC website