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Keeping Track: FDA Delays Elagolix, Mylan Eyes For Neulasta Biosimilar Approval, And Duvelisib Gets Priority Review

Executive Summary

The latest drug development news and highlights from our US FDA Performance Tracker.

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In unusual move, labeling lists data supporting use as nerve block as well as other trials that 'do not support' a broader nerve block indication beyond brachial plexus; labeling includes data on reduced opioid use but notes clinical benefit has not been established.

Keeping Track: Delay (For Celgene), Delay (For Allergan), Goose! (Approval For Lilly)

The latest drug development news and highlights from our US FDA Performance Tracker.

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