FDA monthly preview: Key September decisions to watch
Several FDA decisions across multiple specialties are expected this month.
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By
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Kathryn Wighton
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August 28, 2026
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1
The FDA has set multiple PDUFA dates in September 2026 for various investigational therapies targeting serious conditions.
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2
TLX101-Px aims for approval as a PET imaging agent for glioma, with a PDUFA date of September 11, 2026.
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3
Zidesamtinib, an investigational ROS1-selective inhibitor, has a PDUFA target action date of September 18, 2026.
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4
UX111, a gene therapy for Sanfilippo syndrome type A, has a PDUFA action date of September 19, 2026.
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5
Mavacamten's supplemental application for obstructive hypertrophic cardiomyopathy in adolescents is due for review on September 30, 2026.
