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 ...
PhillyVoiceOpinion
FDA's abrupt flip‑flop on Moderna's mRNA flu shot highlights growing risks to drugmakers of investing in vaccines
Incentives to bring vaccines to market are shrinking. Drugmakers are scaling back research investments and cutting jobs.
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.
Straight Arrow News (English) 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 ...
Yahoo
FDA rejects Moderna’s mRNA flu vaccine application - for reasons with no basis in the law
Add Yahoo as a preferred source to see more of our stories on Google. In December 2025, Moderna submitted an application to the FDA to approve the first mRNA-based flu vaccine. Catherine Falls ...
Hosted on MSN
FDA declines to review Moderna’s seasonal flu mRNA vaccine
The US Food and Drug Administration (FDA) has refused to review Moderna’s seasonal influenza jab, mRNA-1010, as the shifting vaccine landscape within the country continues to prove volatile for pharma ...
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 ...
The Hill
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.
FDA refuses to review Moderna’s mRNA flu vaccine application
FDA refuses Moderna's mRNA flu vaccine application, citing inadequate study design, as the company disputes decision, saying it contradicts prior FDA guidance.
Detroit News
FDA reverses course and will review Moderna’s mRNA-based flu shot
The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu vaccine under a revised approach, company and federal officials said ...