Key Takeaways
- The time between submission and approval continued to creep upward in 2024, with a median of 11.7 months for the US FDA’s novel approvals.
- The past year saw no extreme outliers in review times, which ranged from a low of 6.4 months for Genentech’s Itovebi to a high of 58.6 months for Mesoblast’s Ryoncil.
- The FDA missed five user fee goal dates for novel approvals, continuing a move away from strict PDUFA compliance that began during the COVID-19 pandemic.
The median review times for US Food and Drug Administration-approved novel agents in 2024 held very close to Prescription Drug User Fee Act goals, highlighting the fundamental predictability of the...
The total of 61 NMEs and novel biologics approved in 2024 produced an 11.7-month median review time.
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