Big Totals And Big Margins: US FDA Approved 72 Novel Agents In 2023 – And Acted On 90+

US FDA’s biologics center posted a historic 17 novel approvals, blowing past previous records, while the drug center’s 55 novel agents was close to its 21st century high.

scaling-FDA-approval-heights
US FDA scaled new heights in 2023 with record-breaking approval totals. • Source: Shutterstock

2023 was a spectacular year for novel drug and biologic approvals at the US FDA, where the drugs and biologics centers combined for a total of 72 novel agent approvals – not just a historic high, but one with a margin of seven approvals over the previous high of 65 in 2018.

The Center for Drug Evaluation and Research contributed 55 new molecular entity and novel therapeutic biologic approvals to the 2023 total, second only to 2018’s 59 approvals

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