5 Key Takeaways

• 1

  The FDA is set to make key regulatory decisions in October 2026 regarding multiple therapies for various cancers and other conditions.

• 2

  Atezolizumab's application for colon cancer treatment received Priority Review, based on the phase 3 ATOMIC trial results.

• 3

  Ifinatamab deruxtecan's application for small cell lung cancer also received Priority Review, supported by phase 2 trial results.

• 4

  Satralizumab's application for thyroid eye disease is under Priority Review, with significant efficacy demonstrated in phase 3 trials.

• 5

  Bepirovirsen's application for chronic hepatitis B has been granted Priority Review, showing higher cure rates in phase 3 trials.