The skinny lineup of applications with US FDA user fee goal dates in July is heavy on incremental benefits from formulation technology, the Pink Sheet US FDA Performance Tracker’s User Fee Goal Dates tracker shows.
Key Takeaways
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The FDA’s workload in July could ease up with only eight PDUFA goal dates, including just two novel agents, one breakthrough therapy designation, and no priority reviews.
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Novo Nordisk’s insulin icodec looks unlikely to see approval for broad diabetes claim after an FDA advisory committee, but the indication may be limited to type 2 diabetes
Even the two novel agents on the calendar, Sun Pharmaceutical Industries Ltd
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