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

 
• By Bridget Silverman and Neena Brizmohun

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.

US & EU Approvals
Fifty-five novel products were approved in either the US or EU during the first half of 2021.

The US and the EU both posted impressive numbers of novel approvals in the first half of 2021, but with little overlap.

Only three of the 32 new molecular entities and novel biologics authorized by the US Food and Drug Administration had...

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