Pixclara (floretyrosine F 18; TLX101-Px) is a Telix Pharmaceuticals Limited program in PET imaging to characterise recurrent or progressive glioma from treatment-related changes. The FDA approved it on Sep 11, 2026. 1 FDA decision on record below. Every date links its source.
All upcoming FDA decision dates on the 2026 PDUFA calendar
FDA approval tracked on pdufa.bio: PET imaging to characterise recurrent or progressive glioma from treatment-related changes (approved Sep 11, 2026). Earlier approvals may not be listed here; the FDA label is the full record. Sponsor: Telix Pharmaceuticals Limited (TLX). Approval record: NDA approved (announced September 14, 2026; goal date September 11) after a March 16, 2026 resubmission following an earlier Complete Response Letter. Pixclara is the first FDA-approved FET-PET imaging agent for glioma, indicated to help differentiate recurrent or progressive glioma from treatment-related change in adults and pediatric patients. Market-cap tier at the time we tracked it: Mid. We track 1 catalyst event for this program: 0 upcoming and 1 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.
No upcoming catalyst is on our calendar for Pixclara (floretyrosine F 18; TLX101-Px); 1 FDA decision is on record below.
On Sep 14, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.
In our records Pixclara (floretyrosine F 18; TLX101-Px) is FDA-approved for PET imaging to characterise recurrent or progressive glioma from treatment-related changes (approved Sep 11, 2026). Other approved uses may not be tracked here; the FDA label is the full record.
Telix Pharmaceuticals Limited (TLX).
Yes. The FDA approved an application for Pixclara (floretyrosine F 18; TLX101-Px) on Sep 14, 2026; the decision page linked above carries the source.
FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.