FDA reverses course, will review Moderna's mRNA flu vaccine
Moderna said it met with the FDA on Tuesday to discuss the vaccine and afterward, the U.S. regulator accepted a revised ...
Straight Arrow News on MSN
FDA to review Moderna's mRNA flu vaccine after initial rejection
Moderna announced that the FDA will review its new mRNA flu vaccine, a reversal less than two weeks after the agency refused to do so. The post FDA to review Moderna's mRNA flu vaccine after initial ...
CIDRAP
Double-reverse: FDA now says it will review Moderna’s mRNA flu vaccine
One week after saying it was refusing to review Moderna’s application for approval of a new flu vaccine, the US Food and Drug Administration's (FDA’s) Center for Biologics Evaluation and Research ...
FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal
The FDA is slated to make a decision on the flu shot on Aug. 5, which will allow Moderna to make the vaccine available for the upcoming influenza season.
FDA Refuses to Review Moderna’s New Flu Shot
At issue with Moderna's mRNA flu shot is communication from CBER to Moderna suggesting that the company’s vaccine be compared against a control shot designed more specifically for older people.
Moderna says FDA to review its flu vaccine after reversing course
With the reversal from the FDA, Moderna said it is aiming to make the vaccine available for the 2026-27 flu season.
Dermatology Advisor
Moderna’s mRNA Flu Vaccine Back Under FDA Review
The FDA agreed to review Moderna’s experimental mRNA influenza vaccine after Moderna resubmitted its application with modifications.
FDA declines to review Moderna’s new flu vaccine
The FDA rarely refuses to file an application, particularly for a new vaccine, which requires companies and FDA staff to engage in months or years of discussions. Moderna has requested an urgent ...
The Baltimore Sun
FDA agrees to review Moderna mRNA flu vaccine after initial refusal-to-file
The Food and Drug Administration reversed course on Wednesday and agreed to formally review Moderna’s new flu vaccine that uses mRNA technology, the company announced in a news release. Earlier this ...
FDA reverses course, will review Moderna’s mRNA flu vaccine candidate
The Food and Drug Administration (FDA) has backtracked its initial decision last week of refusing to review Moderna’s mRNA flu vaccine candidate after holding a high-priority meeting with the company.
U.S. FDA changes course and agrees to review Moderna's mRNA flu vaccine application
Moderna says the U.S. Food and Drug Administration (FDA) has agreed to review its influenza ‌vaccine, reversing an earlier decision to reject the application, following modifications from the company.
FDA to review Moderna mRNA flu vaccine
The FDA will review Moderna’s new mRNA flu vaccine after reversing course, raising fresh concerns about potential setbacks ...