FDA monthly preview: Key October decisions to watch

Several FDA decisions across multiple specialties are expected this month.

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The FDA is set to make key regulatory decisions in October 2026 regarding multiple therapies for various cancers and other conditions.
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Atezolizumab's application for colon cancer treatment received Priority Review, based on the phase 3 ATOMIC trial results.
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Ifinatamab deruxtecan's application for small cell lung cancer also received Priority Review, supported by phase 2 trial results.
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Satralizumab's application for thyroid eye disease is under Priority Review, with significant efficacy demonstrated in phase 3 trials.
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Bepirovirsen's application for chronic hepatitis B has been granted Priority Review, showing higher cure rates in phase 3 trials.

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