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 ...
STAT1d
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.
BioSpace1d
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 Pharma1d
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 ...
The Latest: Mass layoffs begin at the US Department of Health and Human Services
Employees across the U.S. Department of Health and Human Services began receiving notices of dismissal Tuesday, as part of a ...
STAT3d
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 ...
Fox Business14d
Nearly 200,000 Target brand canned vegetables under FDA urgent recall due to 'foreign object'
Hundreds of thousands of Target brand canned vegetables were recently recalled by the Food and Drug Administration (FDA) in nearly two dozen states. Good & Gather, Target's store brand ...
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 Alpha15d
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 ...
Reuters15d
US FDA expands approval for Alnylam's drug to treat rare heart disease
Alnylam's Amvuttra first to treat both nerve and heart forms of ATTR-CM Pricing strategy crucial for Amvuttra's market share against oral options Alnylam is banking on the success of the drug ...