Moderna received what’s called a “refusal-to-file” letter from the FDA that objected to how the company conducted a ...
The Food and Drug Administration rejected Moderna’s application for its mRNA-based flu vaccine, the drugmaker said Tuesday ...
Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna has ...
The decision, which shocked company officials, comes as the FDA says it will take a stricter approach to federal vaccine ...
Moderna said its new flu shot has been cleared for review in Australia, Canada and the European Union. It has asked to meet ...
During the first year of the Trump administration, signs of an anti-mRNA slant within the FDA and the Department of Health ...
Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent ...
Moderna shares sink 10% after FDA issues Refusal-to-File letter for its mRNA-1010 flu vaccine, citing trial design concerns ...
The vaccine maker’s shots involve the successful Covid vaccines’ RNA technology. Health Secretary Robert F. Kennedy Jr. has ...
The Food and Drug Administration is refusing to consider Moderna's application for a new flu vaccine made with mRNA technology, the company said.
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