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Moderna Files FDA Application for the LP.8.1 Targeting COVID-19 Vaccine
CAMBRIDGE, MA / ACCESS Newswire / May 23, 2025 / Moderna, Inc. (NASDAQ:MRNA) today announced that it has submitted an ...
The New Covid-19 Jab Policy Wasn’t Up for Debate at the FDA’s Vaccine Meeting. Major Questions Remain.
The framework the new FDA leaders laid out on Tuesday raised small and big questions about the regulatory process, vaccine ...
With vaccine approval process set to change, FDA advisers leave wiggle room in annual Covid-19 shot recommendations
A group of experts who advise the US Food and Drug Administration on its vaccine decisions voted unanimously Thursday to make ...
Here's what to know about the FDA's COVID-19 vaccine changes
The FDA will limit the vaccine’s availability later this year to older adults and those who may be at risk of severe illness.
FDA to limit COVID-19 boosters for 'low risk' people under 65. What to know in Tennessee
Healthy and under the age of 65? You might not need to receive an annual COVID-19 booster. What to know about new guidelines.
FDA Plans to Limit COVID-19 Vaccines to High-Risk Groups
In an editorial article published in the New England Journal of Medicine, Dr. Vinay Prasad, the newly appointed head of the ...
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FDA committee recommends formula for fall COVID-19 vaccines
An FDA committee on Thursday recommended that COVID-19 vaccines for the 2025-2026 respiratory virus season — which, for the ...
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FDA Vaccine Advisors Agree on COVID-19 Vaccine as New Framework Looms as ‘Elephant in the Room’
The advisory committee meeting comes days after the FDA unveiled a new risk-based approval framework for COVID-19 vaccines.
FDA Updates COVID-19 Vaccine Regulations—Here’s What to Know
The FDA has updated COVID-19 vaccine regulations. Only people aged 65 and up, along with certain groups, will be eligible to ...
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FDA’s New COVID-19 Vaccine Approval Policy May Limit Future Access
The FDA is implementing stricter guidance for the approval of COVID-19 vaccines, according to a paper published in The New England Journal of Medicine.
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FDA tells vaccine makers to expand warning labels on COVID-19 shots
The FDA has told vaccine manufacturers to expand the warning labels on their COVID-19 shots with more information about the ...
FDA will approve COVID-19 vaccine only for older adults and high-risk groups – a public health expert explains the new rules
The agency said it would approve new versions of the vaccine only for adults 65 years of age and older as well as for people with one or more risk factors for severe COVID-19 outcomes. These risk ...