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Less Than First: Below-Average Innovation In US FDA’s Big 2023 Novel Approval Haul

 
• By Bridget Silverman

Innovation metrics like first-in-class and breakthrough therapy approvals declined as a share of novel agents in 2023, even as the US FDA’s drugs center posted one of its biggest novel approval totals ever.

below average
The US FDA approval class of did not get strong marks in some areas. • Source: Shutterstock

The US FDA’s Center for Drug Evaluation and Research posted its second-highest annual total novel approvals of the PDUFA era in 2023, but the class is actually below average on some important markers of innovation: first-in-class drug approvals and breakthrough therapy designations.

CDER approved 20 new molecular entities and novel biologics that were first in their class during 2023, the same number of first-in-class novel agents that were approved in 2022

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