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FDA, Covid

FDA will limit Covid vaccines to people over 65 or at high risk of serious illness, leaders say

will require manufacturers to conduct clinical trials to show whether the vaccines benefit healthy younger adults and children

STAT · 1d

· 18h · on MSN

New FDA chiefs limit Covid-19 shots to elderly, sick

· 1d · on MSN

FDA Changes May Limit COVID Vaccine Access—Drawing Some Criticism. Here’s What We Know

FDA may limit future Covid-19 shots to older people and those at risk of serious infection

Millions of healthy adults and kids will likely lose access to updated vaccines under the new criteria.

· 1d

· 9h

FDA limits access to COVID-19 vaccine to older adults and other high-risk groups – a public health expert explains the new rules

Axios · 1d

New COVID booster rules could limit shots for people under 65

FDA’s Makary: Covid shot guidance coming soon

FDA Commissioner Marty Makary announced Thursday that the agency will soon provide clear guidelines to vaccine manufacturers for annually updating their Covid-19 shots.

11h

FDA Commissioner Makary Cites Real Clear Journal Article At Panel On Talc In The American Food Supply

"Expert Panels with the FDA" are a series of roundtable discussions to provide an open public discourse on the latest medical and scientific information on several important topics. At this roundtable,

Fierce Pharma1d

FDA lays out stricter COVID vaccine policy in pivot from 'one-size-fits-all' approach

The FDA is tightening its regulatory policy around COVID vaccines with a new framework that raises the bar for certain approvals. | FDA Commissioner Marty Makary, M.D., and CBER head Vinay Prasad, M.D.

BioSpace3d

Makary’s ‘Conditional Approval’ Pathway for Rare Diseases Poses More Questions Than Answers

While sparking excitement among biopharma companies focused on rare and ultrarare indications, experts say FDA Commissioner Marty Makary’s proposal is light on details and raises potential concerns about safety,

1don MSN

Psychedelic stocks rise as FDA chief’s comments seen favorable to industry

Companies focused on psychedelic medicines traded higher for the second straight session on Tuesday after FDA Commissioner Marty Makary said evaluating the potential of psilocybin, MDMA, and other psychedelics will be a “top priority” under the Trump administration.

1don MSN

FDA sets new COVID booster guidelines requiring trials for approvals for healthy adults

The U.S. Food and Drug Administration plans to require new clinical trials for approval of annual COVID-19 boosters for healthy Americans under 65, effectively limiting their availability later this year to older adults and those at risk of developing severe illness,

BioSpace2d

FDA Grants Narrow Approval of Novavax’s COVID Shot as Makary Teases Changes to Vaccine Approval Framework

The restrictions on Novavax's vaccine could portend changes at the FDA. Commissioner Marty Makary suggested last week that the agency could update its vaccine approval guidelines “in the coming days.”