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FDA monthly preview: Key September decisions to watch

Several FDA decisions across multiple specialties are expected this month.

  • By

  • Kathryn Wighton

  • August 28, 2026

  • 5 min

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  • 1

    The FDA has set multiple PDUFA dates in September 2026 for various investigational therapies targeting serious conditions.

  • 2

    TLX101-Px aims for approval as a PET imaging agent for glioma, with a PDUFA date of September 11, 2026.

  • 3

    Zidesamtinib, an investigational ROS1-selective inhibitor, has a PDUFA target action date of September 18, 2026.

  • 4

    UX111, a gene therapy for Sanfilippo syndrome type A, has a PDUFA action date of September 19, 2026.

  • 5

    Mavacamten's supplemental application for obstructive hypertrophic cardiomyopathy in adolescents is due for review on September 30, 2026.

Original Source(s)

FDA monthly preview: Key September decisions to watch

  • by Kathryn Wighton

  • August 28, 2026

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