CPI-613 receives FDA orphan drug designation for soft tissue sarcoma

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CPI-613 (devimistat) received Orphan Drug designation from FDA for the treatment of soft tissue sarcoma.

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Companies vying for accelerated approval and devising strategies for confirmatory trials would be best served by seeking prospective sign-off from FDA, agency officials say.  Officials from the FDA Oncology Center of Excellence described these best practices in a perspective piece in the Sept. 21 issue of The New England Journal of Medicine and discussed the...