US FDA’s June Approvals Forecast: Nearly 30 Goal Dates Suggest Hot Start To Summer

June goal dates include RSV and pneumococcal vaccines, two COPD therapies, Rocket and Sarepta gene therapies, and lots of oncology.

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The month of June could be among the busiest for US FDA approvals in 2024 to date, thanks to a stacked user fee goal date calendar that features nine novel agents and 13 potential new indications, according to the Pink Sheet US FDA Performance Tracker’s User Fee Goal Dates chart.

Six of the novel candidates are being reviewed by the FDA’s Center for Drug Evaluation and Research. Barring an unusual...