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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FDA has approved over 50 new molecular entities in a year for the second time – a truly remarkable job amid a global pandemic. But will 2021 be a tougher year?
With goal dates for almost 40 novel drugs and biologics coming up in the second half of 2020 after a record number of first half approvals, even the pandemic looks unlikely to prevent another solid year for innovative drugs at US FDA.
Despite the emergence of the coronavirus pandemic at the end of the period, Japan’s regulatory authorities maintained an annual pace of new drug approvals on a par with the previous year, with expedited programs helping several drugs to market.