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Breakthrough Therapy

Meaning

Breakthrough Therapy is a designation granted by regulatory bodies, such as the $text{U.S.}$ Food and Drug Administration ($text{FDA}$), to expedite the development and review of a drug intended to treat a serious or life-threatening condition. To qualify, preliminary clinical evidence must indicate that the therapy may demonstrate substantial improvement over existing therapies on clinically significant endpoints. This designation is a regulatory tool designed to accelerate patient access to promising new treatments, particularly in areas of high unmet medical need.