News

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 ...
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FDA chief pushes back on senators’ criticism, says Covid booster trials should take ‘roughly a year’
The hearing was supposed to focus on the Trump administration’s 2026 budget request, but instead covered a wide range of ...
The FDA Takes a Trial-Lawyer Turn
Commissioner Makary touts dubious evidence on talcum powder at a rushed hearing.
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‘Didn’t You Say That?’: Democratic Senator Decimates FDA Chief
The Commissioner of the Food and Drug Administration, Marty Makary, came under strong criticism for his inconsistent remarks ...
FDA panel debates COVID vaccine recipe as questions swirl about fall shots
Government vaccine advisers are meeting to decide if the recipe for COVID-19 vaccines needs updating for this fall and winter ...
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 ...
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 ...
BioSpace2d
Makary Backs Psychedelics for Neuropsych, Promises Speedy Review
In an interview on Friday, FDA Commissioner Marty Makary threw his weight behind psychedelic therapies, noting that patients ...
New FDA chiefs limit Covid-19 shots to elderly, sick
FDA Commissioner Dr. Marty Makary and vaccine chief Dr. Vinay Prasad set stricter approval standards for booster shots ...
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FDA will limit Covid vaccines to people over 65 or at high risk of serious illness, leaders say
The FDA announced it will limit access to Covid-19 vaccines going forward to people 65 and older and others at high risk of ...
BioSpace3d
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 ...
Psychedelic stocks rise as FDA chief’s comments seen favorable to industry
Psychedelic drug developers rise as the FDA chief Marty Makary says evaluating psychedelics will be a “top priority” under ...