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US FDA Ends 2019 With Second-Highest Approval Count After Second-Half Rebound

 
• By Michael Cipriano

CDER's 48 novel agents, including 35 in the second half of the year, marks the second-highest novel approval count in the contemporary era.

Pink Sheet Perspectives 2019 to 2020
CDER Approved 48 novel agents in 2019, the second highest total of the contemporary FDA.

Sponsors had an exceptional second half of 2019 in obtaining novel drug and therapeutic biologic approvals from the US Food and Drug Administration after struggling during the first six months. And the strong finish resulted in the second-highest novel approval count in a contemporary calendar year.

The FDA's Center for Drug Evaluation and Research (CDER) cleared 35 new molecular entities (NMEs) and novel biologic entities (NBEs) in the second half of 2019, bringing the total for the year to 48

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