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US FDA’s Best Year Ever For New Drugs: CDER Novel Approvals Hit 59

 
• By Bridget Silverman

FDA’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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FDA may be partially shutdown, but the agency should still celebrate its drug approval totals for 2018.

More than 90% of the US FDA’s Center for Drug Evaluation and Research actions on applications for novel agents were approvals in 2018, carrying the agency to its largest annual approval count since the modern era of the FDA was initiated by Prescription Drug User Fee Act of 1992.

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