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Breakthrough Designation Binge In February By US FDA Didn’t Extend To Approvals

 
• By Bridget Silverman

Six new breakthrough therapy designations have been announced, all for novel agents, but approvals were fewer and limited to new indications and formulations.

Rare disease hands
• Source: Shutterstock

Amidst a continued chilly environment for novel approvals, the US FDA’s breakthrough therapy designation (BTD) program has been generating heat this month, with seven new awards announced in February, the Pink Sheet’s US FDA Performance Tracker shows.

While seven BTD announcements over about four weeks is hardly unprecedented, it does put February 2024 in the upper reaches of the busiest times for new designations

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