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US FDA’s Breakthrough Designation Pace Slows, But Topics Broaden

 
• By Bridget Silverman

The 19 breakthrough therapy designations awarded so far this year run the gamut from areas that traditionally have not fared well with BTDs, like cardiovascular and respiratory disease, alongside the traditional cancer and orphan disease tentpoles.

Breakthrough slow down
The pace of designations for the fastest ways to get through FDA are slowing down. • Source: Nielsen Hobbs; the Pink Sheet| Shutterstock images

US FDA’s flagship expedited review programs – the breakthrough therapy designation and its younger cousin, the biologics-focused regenerative medicine advanced therapy designation – have added new designations at a slower pace than the peak a few years ago.

Those designations that have been announced this year, however, illustrate the widening scope of the programs beyond the oncologics and rare disease therapies that made up the bulk of the...

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US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
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EU CHMP Opinions And MAA Updates

 
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