FDA+ roundup: CDER’s breakthrough designation requests see steep decline in 2021; Drugmakers call to expand FDA guidance on PD-(L)1 dosing

The once never-ending rise of breakthrough designation requests at the FDA slowed again in 2021, with just over 100 requests coming into the agency, compared to 156 just two years ago.

In addition to the decline in requests, there was also a substantial drop off in approvals: FDA hasn’t approved...

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