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.
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.
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