FDA response letter

FDA
MedTech

Production problems hamper Lantheus FDA approval of dx kit

The FDA dealt Lantheus’ bid for approval of its radiodiopharmaceutical diagnostic kit a setback due to manufacturing issues at a third-party facility.
Joseph Keenan Jun 29, 2026 8:31am
Lots of nos

Mesoblast hit by FDA rejection, request to run another trial

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