The FDA accepted Telix Pharmaceuticals’ resubmitted NDA for TLX101-Px (Pixclara), a radiolabeled imaging agent for characterizing progressive or recurrent glioma across adult and pediatric patients. The agency set a Sept. 11, 2026 PDUFA date, putting the product on a defined regulatory timeline. TLX101-Px is intended to support imaging workflows in glioma, where accurate characterization of progression status can affect treatment selection. For diagnostic developers, NDA acceptance after resubmission is a critical step that signals regulators found the package sufficient to proceed. The accepted review also provides a near-term catalyst for the company’s commercial planning, including imaging center readiness and reimbursement strategy. In parallel, it highlights the FDA’s willingness to restart formal review when companies correct earlier issues. For the broader biotech community, this is another datapoint that radiopharmaceutical diagnostic NDAs continue to clear regulatory hurdles when clinical and chemistry controls are aligned with FDA expectations.