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US And EU Approvals In First Half 2021 Underscore US-First Orientation Of Novel Drug Development

Executive Summary

Close to 90% of the FDA’s 2021 first half novel approvals were cleared in the US before Europe, while the EU’s EMA acted first on only 15% of its first half marketing authorizations for new active substances. Exclusive Pink Sheet analysis explores use of expedited review schemes, special pathways and other comparative trends.

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