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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Oncology R&D isn’t waning, but investment in neurology and psychiatry drug development are paying off in new drug approvals. Rapid growth in CDER non-malignant hematology approvals reflects longer, broader trend toward orphan drugs.
The US FDA issued at least 33 complete response letters to sponsors in 2019, although only one went to a biosimilar candidate.
The latest news on novel drug approvals and complete response letters from our US FDA Performance Tracker.