MedCity News2d
Ouster of Peter Marks & Mass FDA Layoffs Have Biotech Sector Bracing for Regulatory Disruptions
As the FDA’s top biologics official, Peter Marks oversaw regulation of cell and gene therapies. The departure of Marks and ...
Fierce Pharma2d
FDA taps insider Scott Steele to lead CBER on acting basis after Peter Marks departure
Amid a dramatic reshaping of the federal healthcare apparatus, the FDA has named an acting leader of its Center for Biologics Evaluation and Research. | Amid a dramatic reshaping of the federal ...
Ousted FDA vaccine director calls Kennedy’s start ‘very scary’
Kennedy Jr., warned in an interview published Friday that Kennedy’s tenure at the HHS has been “very scary” so far. Marks ...
Fierce Pharma4d
As FDA's Peter Marks resigns, industry watchers size up vaccine, cell and gene therapy hits
As the FDA wavers from cuts, changes and departures under the second Trump administration, another vital figure of the agency ...
BioSpace1d
FDA Layoffs Continue as Former Commissioner Robert Califf Speaks Out
The latest cuts, which are part of a larger reduction of 10,000 at the Department of Health and Human Services, were ...
BioSpace2d
Scott Steele Steps In as FDA’s Interim CBER Head After Marks’ Departure
Following the dramatic late-night resignation of Peter Marks last Friday, Steele, a senior advisor to the division, takes the ...
US FDA insider Steele replaces Marks as top vaccine official, for now
The U.S. Food and Drug Administration said on Tuesday it had named Scott Steele as acting director of its Center for ...
MassDevice3d
Mass layoffs start at HHS: ‘FDA as we’ve known it is finished’
"The ongoing gutting of the FDA is likely to cause American deaths," said the CEO of one medical device developer.
'Decapitated': More top vaccine regulators out at FDA, threatening new approvals
More top vaccine regulators at the FDA have either left or been forced out, which could hobble the agency's ability to ...
FDA delays full approval of Novavax Covid-19 vaccine even though it was on track for clearance
The US Food and Drug Administration has delayed granting full approval of Novavax’s Covid-19 vaccine despite it being on ...
Top vaccine official forced out of FDA
The head of the US Food and Drug Administration department responsible for assuring the safety and effectiveness of vaccines ...