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Keeping Track Of Breakthrough Therapy Designations: Depression, Headaches, Hepatitis

 
• By Michael Cipriano and Nielsen Hobbs

The latest developments in one of the US FDA's favorite pathways.

Sparks

Some sponsors are enjoying an extra serving of regulatory cranberry sauce this week after their development programs received a breakthrough therapy designation (BTD) from the US FDA.

COMPASS Pathways announced a breakthrough therapy designation Oct

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Tougher Approval Standards May Follow Vinay Prasad’s Appointment To Lead US FDA’s CBER

 
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US FDA Expands Surprise Foreign Inspections But Loses Associate Commissioner Michael Rogers

 
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