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 ...
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 ...
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 ...
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 ...
Bread sold in six states recalled over ‘glass fragments’: FDA
The rolls were sold at the retail level in Pennsylvania, California, Connecticut, Maryland, Delaware, and Ohio, according to ...
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 ...
STAT5h
Amid FDA chaos, approval of a rare disease drug gets delayed — again
Stealth BioTherapeutics had expected the FDA to respond on Tuesday to its marketing application for elamipretide to treat ...
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 ...
Rolling Out18h
The FDA just walked away from dairy safety testing
The FDA has paused its dairy quality control testing program due to laboratory support issues, prompting concerns about ...
Health on MSN19h
FDA Suspends Key Milk Safety Program—What This Means For You
The FDA has paused a quality control program for milk and dairy products. Food safety experts are concerned, but they say our ...
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 ...
Becker's Hospital Review11m
1st pediatric patient receives FDA-approved gene therapy
At Children’s Hospital of Philadelphia, an 11-year-old girl with severe beta thalassamia, became the first pediatric patient to receive Zyntelgo, the first FDA-approved gene therapy for ...