Documentary record · APPROVAL
Pixclara (floretyrosine F 18) approved as a PET imaging drug for glioma
APPROVED
Event date
September 14, 2026
Jurisdiction
United States
Issuing body
U.S. Food and Drug Administration (announced by the sponsor)
Action type
APPROVAL
Lifecycle state
APPROVED
Verification date
15 September 2026
Legal effect
A marketing approval for a diagnostic radiopharmaceutical. It does not determine coverage.
What this establishes
- Telix Pharmaceuticals announced on 14 September 2026 that FDA approved Pixclara for use with PET to differentiate recurrent or progressive glioma from treatment-related change, in conjunction with other diagnostic evaluations, in adults and children aged 1 month and older.
- The FDA goal date had been 11 September 2026. The sponsor describes it as the first FDA-approved FET-PET agent for glioma.
What this does not establish
- FDA’s own approval date or label text, which this record has not yet read.
- Coverage or availability at any imaging centre.
Why it matters
Distinguishing tumour progression from treatment effect is one of the hardest calls in brain-tumour follow-up; an approved agent changes what can be ordered, not what a payer must cover.
Primary source
Related on this site
Register: the record store · record id fda-pixclara-glioma-pet-2026-09-14.