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With 37 Novel Approvals in 2022, US FDA CDER’s Five-Year Hot Streak Comes To An End; Gene Therapies Carry CBER To 8 Novel Approvals

Executive Summary

US FDA’s novel agent count fell back to average as agency kept up high rate of complete response letters and refuse to file actions; CBER’s workload shifted to regenerative medicine.

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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.

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

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.

Finance Watch: Mega-Rounds Make A Comeback, But Will VC Funding Totals Rise Too?

Private Company Edition: Venture capital mega-rounds of $100m or more held steady in April after a slow January and February then a surge in March, but VC fundraising is down overall this year. In recent raises, Enveda series B expanded to $119m, Vedanta brought in $106.5m and Convergent raised $90m.

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