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FDA response letter
Biotech
Mesoblast hit by FDA rejection, request to run another trial
FDA officials want to see data from at least one more trial, but Mesoblast is still hoping to snag an accelerated approval using its existing data.
Nick Paul Taylor
Oct 2, 2020 8:50am
FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts
Sep 14, 2020 8:25am
Tricida sinks as FDA rejection raises prospect of new trial
Aug 25, 2020 8:20am
FDA rejects Gilead's would-be blockbuster filgotinib
Aug 19, 2020 4:22am
FDA turns back DBV Technologies' peanut allergy patch for kids
Aug 4, 2020 12:28pm
Acacia gets 2nd FDA rejection as manufacturing fault drags on
May 3, 2019 8:28am