gallium Ga 68 gozetotide (Gozellix): FDA status

Approved Approved Mar 20, 2025. Indication: PSMA PET imaging of prostate cancer with suspected metastasis or recurrence. Company: Telix Pharmaceuticals.

Regulatory history

• Mar 20, 2025: Approved. FDA approved PSMA PET imaging agent TLX007-CDx for prostate cancer. OncLive
• Jul 24, 2024: FDA accepted for review. FDA accepted the NDA for TLX007-CDx, a PSMA PET imaging agent candidate, and assigned a PDUFA goal date of March 24 2025. sec.gov

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