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
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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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.
NDA/BLA Approval Totals: Will US FDA Recover From Slow Start Again?
Since 2018, the agency usually has increased its average NDA/BLA approvals per month after April, but the data also suggest an overall downward trend in productivity.
Keeping Track: Travere’s Filspari, Chiesi’s Lamzede, Apellis’ Syfovre Headline US FDA Approvals; CRLs For Phathom, Biocon
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.