FDA response letter

Lots of nos
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 Building 2

FDA rejects Mallinckrodt's kidney drug over risk-benefit doubts

Sep 14, 2020 8:25am
FDA Building 2

Tricida sinks as FDA rejection raises prospect of new trial

Aug 25, 2020 8:20am
Gilead

FDA rejects Gilead's would-be blockbuster filgotinib

Aug 19, 2020 4:22am
Peanuts in shell

FDA turns back DBV Technologies' peanut allergy patch for kids

Aug 4, 2020 12:28pm
FDA Building 2

Acacia gets 2nd FDA rejection as manufacturing fault drags on

May 3, 2019 8:28am