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 ...
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 ...
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 to Unveil Covid Shot Policy as RFK Jr. Eyes More Tests
President Donald Trump’s administration is slated to lay out its approach to Covid vaccination at an event Tuesday that could ...
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 ...