US FDA’s Best Year Ever For New Drugs: CDER Novel Approvals Hit 59
Executive SummaryFDA’s drug center smashes its past records for new molecular entities and therapeutic biologic approvals; with five novel biologics approved by FDA’s biologics center, the agency’s novel approvals reach a stunning total of 64.
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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.
President Trump’s 2019 State of the Union Address broadly touched on the themes of funding childhood cancer research, drug pricing and eliminating HIV.
The pipeline for new drug candidates remains healthy as 2019 begins, with almost 40 novel agents already under FDA review. But the chances of another record-breaking year are threatened by a confluence of safety issues that are putting risk management back in the spotlight – and by the widening ripple effects of the recent US government shutdown.