The controversial subject line appeared to play off the recent frenzy surrounding the release of over three million pages of documents linked to the late convicted sex offender Jeffrey Epstein.
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The FDA’s refuse-to-file letter cited no safety or efficacy concerns for Moderna’s influenza vaccine, mRNA-1010. The company said the agency’s justification for refusing a review is inconsistent with ...
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The U.S. Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with Nobel Prize-winning mRNA technology, the company announced Tuesday.
The agency said it denied Moderna’s application because it refused to follow “very clear” guidance. The drugmakers says the ...
The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.
The FDA issued a rare Refusal-to-File letter to Moderna over its mRNA-based influenza vaccine application, in an unusual move that sent the biotech’s shares tumbling.
Moderna received what's called a "refusal-to-file" letter from the FDA that objected to how it conducted a 40,000-person clinical trial comparing its new vaccine to one of the standard flu shots used ...
Correction: This story was updated to clarify a statement given by Department of Health and Human Services spokesperson Andrew Nixon. Moderna said on Tuesday that the Food and Drug Administration ...