After The Peak Of 2018’s US FDA Approval Record, 2019 Looks Like A Valley

FDA’s second half 2019 user fee calendar features almost 30 novel agents, but another record-breaking tally is out of reach.

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It looks nice, but there's a steep drop.

The US Food and Drug Administration has almost 30 new molecular entity and novel biologics under review with user fee goal dates in the second half of 2019, which all but guarantees a modest annual approval count following on the record high of 2018.

The staggering approval count for 2018 was always going to be hard to match: 65 novel agents were approved last year, including the most ever for the

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