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