US FDA Blows Past Novel Approvals Record On Way To Unprecedented Year For New Drugs
Roche’s Xofluza brings novel approval count for CDER to 47, topping 2017's record – and FDA still has at least 14 novel agents under review with 2018 goal dates.
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FDA’s approval teams cleared a total of 65 new molecular entities and novel biologics in 2018, blowing past previous records. Scrip looks at how that breaks down for industry leaders.
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.
The widely respected agency veteran will still be able to sign off on applications in his new "consultant" role in the Office of New Drugs, in part to help with the increasing workload.