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FDA refuses review of mRNA flu vaccine

Digest more
 · 2d · 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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 · 4d
F.D.A. Refuses to Review Moderna Flu Vaccine
 · 3d · on MSN
FDA defends its decision to refuse review of Moderna's flu vaccine
1don MSN

Moderna reiterates 10% revenue-growth target as Covid vaccine demand falls

Moderna reported falling fourth-quarter sales as Covid-19 vaccine demand continued to drop, but continues to target 10% ...
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 ...
Fierce Pharma
1d

With the FDA's Moderna decision, vaccine makers face increasingly uncertain regulatory environment

Mani Foroohar, M.D., of Leerink Partners, says that the decision reflects “how sharp the departure has been between the prior ...

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