The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
In a rare and surprising move, the FDA has issued a “Refusal to File” letter for Moderna’s mRNA-1010 influenza vaccine.
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...