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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 ...
STAT1d
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 ...
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 ...
The FDA Takes a Trial-Lawyer Turn
Commissioner Makary touts dubious evidence on talcum powder at a rushed hearing.
Fierce Pharma2d
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 ...
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 ...
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 ...
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 ...
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 ...