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Moderna says FDA to review its flu vaccine

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Overview
 · 5h
Moderna says the FDA will consider its new flu shot after resolving a public dispute
The Food and Drug Administration will consider whether to approve Moderna’s new flu vaccine after all, resolving a dispute that had blocked the company’s application for the first-of-its-kind shot.

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 · 10h · on MSN
Moderna says FDA to review its flu vaccine after reversing course
 · 10h · on MSN
FDA reverses course and will review Moderna’s mRNA flu shot, company says
 · 14h
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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 · 13h
FDA Reverses Course and Will Now Review Moderna’s Flu Shot
 · 13h
F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine
BioSpace
14h

Court Rejects Two Moderna Defenses in mRNA Vaccine Patent Row With Arbutus

Arbutus alleges that Moderna’s COVID-19 vaccine infringes on patents protecting its lipid nanoparticle delivery technology.
4h

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.
11h

Stocks to Watch Wednesday: Sandisk, Moderna, Caesars, Kenvue

The FDA agreed to review Moderna's seasonal flu shot after the vaccine maker said it would run extra tests in the elderly.
15hon MSN

Health rounds: Moderna combo flu/COVID vaccine succeeds in mid-stage trial

(This is an excerpt of the Health Rounds newsletter, where we present latest medical studies on Tuesdays and Thursdays.) Feb 18 (Reuters) - A two-in-one mRNA vaccine developed by Moderna that targets seasonal influenza and COVID-19 produced robust and durable immune responses without safety concerns in a small mid-stage trial,
13h

Moderna Shares Gain After New Flu Vaccine Clears Regulatory Hurdle

Shares of Moderna climbed after the Food and Drug Administration accepted for review a revised application for the company's new flu vaccine. The stock gained 6.7%, to $46.89, in premarket trading Wednesday. Through Tuesday's close, shares are up 22% over the past year.
14h

Moderna Announces the U.S. Food and Drug Administration will Initiate the Review of Its Investigational Seasonal Influenza Vaccine Submission

Following a Type A meeting, the FDA's Center for Biologics Evaluation and Research has notified Moderna that its biologics license application for mRNA-1010 will proceed to review

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FDA
flu vaccine
mRNA
United States
Food and Drug Administration
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