The expedited US regulatory pathway for 'breakthrough therapies' has already yielded its first two approvals and more than 26 designations, for 30 candidates in 22 indications.
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Mullard, A. Learning from the 2012–2013 class of breakthrough therapies. Nat Rev Drug Discov 12, 891–893 (2013). https://doi.org/10.1038/nrd4196
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DOI: https://doi.org/10.1038/nrd4196