Clinical Report: FDA Monthly Preview: Key September Decisions to Watch

Overview

The FDA has set several Prescription Drug User Fee Act (PDUFA) dates for September 2026, including key decisions for therapies targeting glioma, ROS1-positive non-small cell lung cancer, and rare diseases. Notable applications include TLX101-Px for glioma imaging and zidesamtinib for ROS1-positive lung cancer.

Background

The FDA's PDUFA dates are critical for the timely review and potential approval of new therapies that address unmet medical needs.

Data Highlights

Key Findings

• TLX101-Px is under review for glioma imaging, with a PDUFA date of September 11, 2026.
• Zidesamtinib is being evaluated for ROS1-positive non-small cell lung cancer, with a PDUFA date of September 18, 2026.
• UX111 aims for accelerated approval in Sanfilippo syndrome type A, with a PDUFA date of September 19, 2026.
• Zilganersen is under review for Alexander disease, with a PDUFA date of September 22, 2026.
• Zilurgisertib is being assessed for fibrodysplasia ossificans progressiva, with a PDUFA date of September 26, 2026.
• Aminolevulinic acid's application seeks to expand its use to superficial basal cell carcinoma, with a PDUFA date of September 28, 2026.
• Tiratricol is under review for monocarboxylate transporter 8 deficiency, with a PDUFA date of September 28, 2026.

Clinical Implications

Clinicians should stay informed about these developments.

Conclusion

The September 2026 PDUFA dates include several investigational therapies.

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