5 Key Takeaways

• 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.