Telix Pharmaceuticals: FDA Accepts Pixclara® NDA, PDUFA Goal Date Set for September 11, 2026

NewTimeSpace News, April 10, 2026,Telix Pharmaceuticals disclosed that the U.S. Food and Drug Administration (FDA) has accepted the company's resubmitted New Drug Application (NDA) for TLX101-Px (Pixclara®, Floetyrosine F 18), an investigational PET imaging agent for the imaging of glioma, and has set a PDUFA goal date of September 11, 2026.

According to the announcement, TLX101-Px has been granted Orphan Drug and Fast Track designations by the FDA, addressing a critical unmet medical need for distinguishing recurrent or progressive glioma from treatment-related changes.

NewTimeSpace Disclaimer: All content herein is the original work of NewTimeSpace. Any reproduction, reprinting, or use of this content in any other manner must clearly indicate the source as "NewTimeSpace". NewTimeSpace and its authorized third-party information providers strive to ensure the accuracy and reliability of the data, but do not guarantee the absolute correctness thereof. This content is for reference only and does not constitute any investment advice. All transaction risks shall be borne by the user.