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Moderna says FDA will consider flu vaccine

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Overview
 · 22h
FDA reverses course, will review Moderna's mRNA flu vaccine
Moderna said on Wednesday the U.S. Food and Drug Administration has agreed to review its influenza vaccine, reversing an earlier decision to reject the application, after the company made modification...

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 · 1d
F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine
 · 1d
Moderna says the FDA will consider its new flu shot after resolving a public dispute
 · 1d
FDA reverses course and will review Moderna’s mRNA-based flu shot
The Food and Drug Administration has reversed course and agreed to review Moderna’s application for the first mRNA-based flu vaccine under a revised approach, company and federal officials said Wednes...

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 · 1d
FDA Reverses Course and Will Now Review Moderna’s Flu Shot
 · 1d
FDA reverses course and will review Moderna’s mRNA flu shot, company says
1d

Moderna got a win from the FDA, but political headwinds remain a concern for vaccine makers

The whiplash over a new potential flu vaccine from Moderna, which went from rejected to approved for review in a matter of days, has illustrated a new reality plaguing the Cambridge biotech company and other vaccine makers: Political headwinds are now an unavoidable and unpredictable factor in their business model.
STAT
8d

Confidence in safety of certain vaccines is dropping

The FDA refused to review Moderna’s application for a new flu vaccine, the company said yesterday. It’s a surprising decision that could raise concerns about the agency’s posture toward drug companies and, of course, the administration’s policies on vaccines overall.
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