FDA Refuses to Review Moderna’s New Flu Shot

The flu vaccine is its first using mRNA technology for influenza.

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...
C&EN

‘Regulatory whiplash’ as FDA decides to review Moderna flu shot

The US Food and Drug Administration will now review Moderna’s new, messenger RNA–based flu vaccine after all, reversing course on a decision that rocked the biopharmaceutical industry last week.