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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

Healio

FDA reverses decision, will review Moderna’s mRNA flu vaccine

Reversing its initial decision, the FDA has agreed to review Moderna’s messenger RNA-based influenza vaccine for approval, the company announced Wednesday. The reversal about weeks after the FDA sent ...

STATOpinion

The FDA’s Moderna pirouette is one more sign of chaos at the agency

For drugmakers and vaccine developers, an FDA reversal on Moderna's flu vaccine is better than the alternative. But it is ...

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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