FDA planning for fewer food and drug inspections due to layoffs, officials say
Around 170 staff were cut from the FDA's Office of Inspections and Investigations this week as part of wider cuts at U.S.
Judge foils FDA plan to regulate lab-developed tests
The FDA finalized a rule to oversee lab-developed tests as if they were medical devices, prompting lawsuits. Opponents said ...
STAT18h
Makary’s first speech to FDA staff focuses on challenging norms, fighting chronic disease
In recording, Makary said little about specific plans for his agency or about the layoffs that have roiled his workforce.
BioSpace21h
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 ...
Fierce Pharma21h
For struggling cell and gene therapy field, Peter Marks' FDA exit adds even more uncertainty
The sudden resignation of Peter Marks, M.D., Ph.D., from the FDA branch that regulates biological products for humans ...
STAT2d
Ouster of FDA’s Peter Marks alarms a biopharma industry that saw him as an ally
Kennedy Jr., a longtime and visceral critic of pharmaceutical and biotech companies, was nominated by President Trump to be ...
Daily Mail14d
What's next for Butch Wilmore and Suni Williams? NASA reveals plans for duo stuck in space for nine months
After spending nine months on the International Space Station, NASA astronauts Suni Williams and Butch Wilmore have finally made it home. The duo splashed down off the Florida coast aboard ...
U.S. News & World Report14d
FDA Increases Testing For Heavy Metals In Baby Formula
Some products had low or no levels detected. "We look forward to seeing the details of how they intend to implement the plan, and we hope the FDA is providing adequate resources and staffing to ...
Seeking Alpha14d
Lenz Therapeutics outlines Q4 2025 launch plans for LNZ100 amid FDA review progress
Management reiterated expectations for FDA approval of LNZ100 by August 2025 ... in the August 2025 PDUFA date and Q4 2025 launch plans. Strategic focus shifted more heavily towards commercial ...
AOL14d
FDA, HHS announce plans to increase testing for heavy metals, contaminates in baby formula
The plan is called "Operation Stork Speed." "The FDA will use all resources and authorities at its disposal to make sure infant formula products are safe and wholesome for the families and childre ...
Newsweek15d
Robert F. Kennedy Releases New Plan for Baby Formula: What to Know
The announcement comes as Kennedy has touted the effectiveness of a healthy diet in mitigating disease in humans and a week after he ordered the FDA to explore revising the "generally recognized ...