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FDA reverses course

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 application seeking full approval of the shot for adults ages 50 to 64, and accelerated approval for those aged 65 and above, which would require a post-marketing confirmatory study to gain regular approval.

· 2d · on MSN

Moderna says FDA to review its flu vaccine after reversing course

· 2d · on MSN

FDA agrees to review Moderna’s mRNA flu vaccine application in a reversal

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FDA reverses course, agrees to review Moderna’s flu vaccine

The FDA reversed course and told Moderna it would review its application for a new flu vaccine, the company announced ...

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to review ...

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FDA reverses course

FDA reverses course, agrees to review Moderna’s flu vaccine

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

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