News

FDA delays decision on Stealth BioTherapeutics' rare genetic disorder drug
The U.S. Food and Drug Administration has delayed its decision on marketing approval for Stealth BioTherapeutics' treatment ...
US FDA chief says firings won't hinder agency's target dates for drug reviews
The U.S. Food and Drug Administration will meet its targets for completing reviews of new drugs despite mass firings at the ...
US FDA approves first cell-based gene therapy for rare genetic skin disorder
The U.S. Food and Drug Administration approved Abeona Therapeutics' gene therapy for a rare skin disorder on Tuesday. Shares ...
FDA to undo some layoffs, after cuts to inspections and drug safety
Multiple current and laid-off FDA employees said the abrupt layoffs had resulted in delays and disruptions to the agency's ...
FDA issues urgent nationwide recall of bread sold in US found with 'glass fragments'
An urgent recall for hundreds of cases of frozen bread sold throughout the U.S. was issued after the FDA said "glass ...
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Pharmalittle: We’re reading about FDA chaos delaying a rare disease drug, Merck’s U.S. investment, and more
Merck will grow its U.S. manufacturing footprint with a $1 billion plant, making it the latest drugmaker to invest in the U.S ...
FDA may ask Novavax to conduct additional trials of its Covid-19 vaccine to receive full approval
The US Food and Drug Administration has discussed with vaccine-maker Novavax the need for an additional trial of its Covid-19 ...
FDA suspends dairy quality testing amid federal workforce cuts. Is it safe to consume milk?
The testing of Grade A dairy products like pasteurized and raw milk, cheese, and yogurt are currently being paused by the FDA ...
FDA head falsely claims no scientists laid off, as agency shutters food safety labs
The head of the Food and Drug Administration has repeatedly claimed in recent interviews that no scientists have been laid ...
How the FDA Helped Ignite, and Then Worsened, the Opioid Crisis
An investigation into the agency’s repeated violations of its own rules to approve addictive drugs—and its ongoing failure to ...
FDA Chief Dr. Marty Makary leads push to ban artificial food dyes by 2026
The FDA is working with the food industry to eliminate petroleum-based artificial dyes from the U.S. food supply by late 2026 ...
FDA warns unapproved hair-loss product finasteride tied to side effects
A quick spray of medication might seem like an easy way to get thicker hair, but some people say one sold online has left ...