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
| Drug | Indication | PDUFA Date |
|---|---|---|
| TLX101-Px | Glioma imaging | September 11, 2026 |
| zidesamtinib | ROS1-positive non-small cell lung cancer | September 18, 2026 |
| UX111 | Sanfilippo syndrome type A | September 19, 2026 |
| zilganersen | Alexander disease | September 22, 2026 |
| zilurgisertib | Fibrodysplasia ossificans progressiva | September 26, 2026 |
| aminolevulinic acid | Superficial basal cell carcinoma | September 28, 2026 |
| tiratricol | Monocarboxylate transporter 8 deficiency | September 28, 2026 |
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.
Related Resources & Content
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