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FDA unexpectedly nixes new Moderna flu vaccine

Digest more
 · 1d · on MSN
Moderna says FDA refuses to review its application for flu vaccine
Moderna noted the FDA did not identify any specific safety concerns with the vaccine and that the rejection was inconsistent with previous feedback.

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 · 2d
FDA Declines to Review Moderna’s mRNA Flu Vaccine Application
 · 2d
The FDA Refuses To Review Moderna’s Flu Vaccine
BioPharma Dive
3d

FDA refuses to review Moderna’s mRNA flu vaccine

Moderna claimed that the decision, issued by top vaccine regulator Vinay Prasad, was “inconsistent” with prior FDA ...
3d

Moderna Receives Refusal-to-File Letter from the U.S. Food and Drug Administration for Its Investigational Seasonal Influenza Vaccine, mRNA-1010

Refusal to review the submission is inconsistent with feedback at pre-Phase 3 and pre-submission consultations; Moderna ...

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