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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 ...
MedPage Today2hOpinion
A Conversation With FDA Commissioner Marty Makary
Among other things, Makary breaks some news here by stating, for the first time, that there will be no significant ...
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 ...
FDA scrutiny of Novavax COVID-19 vaccine sparks uncertainty about other shots
There’s new uncertainty about updated COVID-19 shots this fall after the Trump administration’s handling of a shot from ...
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 ...
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 ...
MedTech Dive17m
ICU Medical receives FDA warning letter over infusion pumps
Inspectors found ICU Medical made multiple changes to infusion pumps without submitting premarket notifications.
FOX 10 Phoenix1h
FDA issues urgent nationwide recall of bread sold in US found with 'glass fragments'
An urgent recall has been issued for a bread brand sold throughout the U.S. that could contain "glass fragments," according ...
STAT7h
How RFK Jr.’s vaccine criticism is taking hold at the FDA
FDA vaccine oversight is shifting, with increased scrutiny and mixed messaging sparking concerns among health experts.
Fierce Pharma1h
Abeona enters commercial gene therapy arena with FDA nod for Zevaskyn to treat rare genetic skin disease
Persistence has paid off for Abeona Therapeutics and its gene therapy for recessive dystrophic epidermolysis bullosa (RDEB).
STAT2h
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 appears to be slow-walking vaccine approvals
Former government health officials fear the Trump administration is moving to slow-walk vaccine approvals, including by ...