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Keeping Track: Opdivo Extends Label Into Neoadjuvant Lung Cancer; Acadia, Revance Resubmit

Executive Summary

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.

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Acadia’s Nuplazid: US FDA Panel Will Focus On Efficacy For Alzheimer’s Disease Psychosis

Agency questions clinical significance of change in primary efficacy endpoint measured in one study and raises doubts about numerous exploratory analyses for a second study aimed at explaining why Alzheimer’s patient subgroup appeared to derive less benefit than other types of dementia patients.

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BMS Gets First Immunotherapy Approval In Neoadjuvant Lung Cancer, Quickly

Opdivo gets approved by the US FDA for neoadjuvant non-small cell lung cancer, an important new early-stage indication for the anti-PD-1 agent that cleared the agency in roughly two months.

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