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Keeping Track: A Glut Of Big Approvals While Lartruvo Makes Its Market Exit

Executive Summary

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

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Pediatric Data Planning Should Start While Adult Drug Development Is In Its Infancy

Innovative trial designs and biostatistics can make pediatric drug development more efficient, but strategies like extrapolating adult data using bridging biomarkers or Bayesian analyses have complex data requirements that demand coordination and forethought.

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Amivas requested a US tropical disease PRV for intravenous artesunate but FDA has not yet made a decision on eligibility; approval appears to block La Jolla’s competing product, currently under review, for seven years.

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