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US FDA Novel Approvals Total 35 In First Half 2023, Riding Resurgent Biologics Wave

 
• By Bridget Silverman

US FDA’s drug center clears 26 novel agents, changing course from 2022’s disappointing first half, while the biologics center’s smashed two decades of records with nine novel approvals in six months.

big wave
• Source: Shutterstock

Strong approvals performance from both the US FDA’s drug and biologics centers over the first six months of 2023 combined to produce a record-setting first half approvals count of 35 new molecular entities and novel biologics.

The Center for Biologics Evaluation and Research blew through recent metrics with nine novel biologic approvals in the first half of 2023 – a number that is more than CBER’s full-year novel totals for most of the last two decades

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