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Breakthrough Therapy Designations At US FDA Stay Sluggish In 2021

 
• By Bridget Silverman

With 12 new BTDs announced so far this year, 2021 is on pace to match the COVID-19-depressed total number of designations in 2020. Here’s a breakdown of the candidates that have received the designation.

It's been a slow start to 2021 for the BTD pathway. • Source: Shutterstock

The US Food and Drug Administration breakthrough therapy designation program has granted a dozen new BTDs in 2021, including designations for seven novel agents.

As could be expected, oncology was the most fruitful area for awards, accounting for three quarters of the 2021 designations....

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