Pfizer FDA Approval Scrutiny

News

FDA, Covid-19

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 company.

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,

The Washington Post · 8d

FDA to issue new vaccine approval guidance amid questions over coronavirus shots

FDA Commissioner Marty Makary said his agency plans to release a new framework for vaccine approvals in “coming days.”

17hon MSN

What we know about the safety, efficacy of mRNA vaccines amid recent scrutiny

Infectious disease experts say mRNA vaccines have been studied for decades, they are safe and effective, and were instrumental in saving lives during the COVID pandemic.

18hon 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 ...

pharmaphorum1d

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 ...

5don MSN

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.

BioSpace1d

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 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 ...

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 ...

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