1. Pink Sheet

FDA Issues Wave Of "Breakthrough Therapy" Denials

 
• By Kate Rawson

FDA denied 10 requests for breakthrough therapy within a four-week period. The reasons behind the wave of rejections are unclear, but may be inherent to the rollout of the program.

As the first anniversary of “breakthrough” therapy approaches, the Food & Drug Administration delivered a string of rejections to drug sponsors seeking the popular designation.

Within four-week period (July 26-August 23), FDA’s Center for Drug Evaluation & Research denied 10 breakthrough requests and granted no...

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