FDA Refuses To Review Moderna mRNA Flu Vaccine and the US Could Miss Out on Next Generation Fu Shots
In a rare and surprising move, the FDA has issued a “Refusal to File” letter for Moderna’s mRNA-1010 influenza vaccine.
The FDA's requirements that are nowhere to be found in the law creaties uncertainty for companies with pending vaccine ...
Dealbreaker on MSN
Moderna says FDA refusal to review mRNA flu vaccine contradicts federal rules, prior guidance
The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine.
The federal government on Wednesday told its side of the story amid a disagreement with Moderna after the FDA decided to ...
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Moderna Has a Promising New Flu mRNA Vaccine. Trump’s FDA Wants Nothing to Do With It
Senior FDA official Vinay Prasad reportedly overrode his staff in deciding to reject Moderna's application for a new seasonal flu shot.
Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent ...
Stanford scientists have uncovered how mRNA COVID-19 vaccines can very rarely trigger heart inflammation in young men — and how that risk might be reduced. They found that the vaccines can spark a two ...
Two and a half years after Sanofi unveiled to investors a revamped strategy to create an mRNA seasonal flu vaccine, Fierce Biotech has learned that the French pharma has put this pipeline on ice. The ...
The biotech’s licensing pact with Pfizer, revealed last week, will leverage its adjuvant vaccine platform in the development of two undisclosed Pfizer products. After pocketing ...
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