Pfizer FDA Approval Scrutiny - Search News

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FDA will limit approval for seasonal COVID vaccines

CNN on MSN · 1d

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 a broad recommendation about which lineage of the coronavirus should be included in this year’s Covid-19 vaccines,

UPI on MSN · 5d

FDA approves Novavax's COVID-19 vaccine with limitations

The U.S. Food and Drug Administration approved Novavax's COVID-19 vaccine with age restrictions after a six-week delay.

FOX 29 News Philadelphia · 3d

FDA will limit approval for seasonal COVID vaccines: What to know

Healthy younger adults and children will no longer be automatically approved for annual COVID-19 vaccines under a new policy from the FDA.

23hon MSN

COVID shots should target newer strains of JN.1 variant, US FDA advisers say

U.S. Food and Drug Administration advisers unanimously recommended on Thursday that COVID-19 vaccines for the 2025-26 period ...

FDA tightens heart tox warnings on mRNA COVID vaccines

According to the CDC, cases of myocarditis and pericarditis are rare with the vaccines and, in most cases, resolve within a ...

Pfizer’s Talzenna Expansion Fails To Earn FDA Advisory Committee’s Support

The FDA’s independent advisors found Pfizer’s data lacked the precision needed to establish the efficacy of Talzenna in ...

BioPharma Dive4d

Novavax’s COVID vaccine gets FDA approval, but with limits

While the clearance is only for use in certain groups, Novavax’s long-awaited OK is still seen by analysts as a “win” for the ...

How do we know mRNA vaccines are safe and effective? An explainer

This week, mRNA vaccines are set to face intense scrutiny from critics in Congress. Here's an explainer of how we know they ...

5d

Novavax Wins Limited FDA Nod For COVID Shot—Cleared Only For Seniors, High-Risk Groups Amid Safety Scrutiny

The U.S. Food and Drug Administration has granted limited approval to Novavax Inc.'s COVID-19 vaccine, restricting its use to ...

BioPharma Dive2d

Moderna pulls application for combo COVID, flu shot

The announcement, which followed the FDA setting new guidelines on COVID vaccine approvals, erased the stock’s gains from ...

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