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Moderna says FDA to review its flu vaccine

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Overview
 · 8d
F.D.A. Refuses to Review Moderna Flu Vaccine
The vaccine maker Moderna said on Tuesday that the Food and Drug Administration had notified the company that the agency would not review its mRNA flu vaccine, the latest sign of federal health policy...

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 · 3d
What the FDA's rejection of Moderna's flu shot means for the future of vaccines
 · 1h
Moderna stock surges as FDA reverses course, agrees to review new flu shot
 · 10h
FDA Reverses Course and Will Now Review Moderna’s Flu Shot
The Food and Drug Administration reversed course and agreed to begin a review of Moderna’s MRNA 4.03% application to sell a new seasonal flu shot after the vaccine maker agreed to conduct additional t...

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 · 10h
F.D.A. Reverses Decision and Agrees to Review Moderna’s Flu Vaccine
 · 2h
US FDA reverses course, will review Moderna's flu vaccine application
Opinion
BioSpace
1d
Opinion

Moderna’s mRNA Vaccine Refusal Comes Amid Global Advanced Therapies Push

The FDA’s refusal to review Moderna’s mRNA-based flu vaccine is “part of a disturbing pattern” of moving regulatory goalposts, according to Clay Alspach, executive director of the Alliance for mRNA Medicines.
1h

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.
abc7NY
3y

Moderna to sue BioNTech/Pfizer over COVID vaccine

Moderna is suing Pfizer and BioNTech for infringing patents central to Moderna's mRNA technology platform used to develop the COVID vaccine, the company said in a press release Friday. A widely distributed COVID vaccine developed by Pfizer and BioNTech ...
1hon MSN

Booster shots reduce the risks of COVID-19 deaths, study finds

Booster vaccines reduced the risk of COVID‑19-related hospitalization and death, according to a new study of over 3 million adults who had the autumn 2022 vaccine in England. The research, led by the universities of Bristol and Oxford,
Morningstar
5mon

Moderna, Pfizer stocks fall as Trump officials reportedly link COVID shots to child deaths

Stocks of COVID-19 vaccine makers take a dive following Washington Post report, while Moderna stresses multiple agencies have backed their safety Stocks of COVID vaccine makers dropped after the Washington Post reported that Trump administration health ...
Benzinga.com
5mon

4PFE, BNTX : Pfizer, Moderna, BioNTech Stocks Tumble...

Shares of COVID-19 vaccine makers Pfizer Inc (NYSE:PFE), BioNTech SE ADR (NASDAQ:BNTX) and Moderna Inc (NASDAQ:MRNA) are trading lower Friday following a Washington Post report that Trump administration health officials intend to link the vaccines to 25 ...
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