Breakthrough status was introduced in the 2012 FDA Safety and Innovation Act to expedite development and review of a potential new medicine intended, alone or in combination with one or more other drugs, to treat a serious or life-threatening disease or condition, when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints.
Breakthrough Therapy Designations
Listing of all ‘breakthrough’ drugs, including status and basis of designation. Updated weekly.
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Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.