News

FDA Layoffs Could Compromise Safety of Medications Made at Foreign Factories, Inspectors Say
For years, inspectors have uncovered dirty equipment, contaminated supplies and fraudulent testing records in some overseas factories — serious safety and quality breaches that can sicken or kill ...
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Sarepta’s Wild Week, CDER’s New Leader, FDA Rejections, Manufacturing Billions
Sarepta Therapeutics faces serious FDA action after news broke of a third patient death, the FDA gets a new top drug ...
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Sarepta stands behind Elevidys after FDA requests gene therapy be pulled from market
As the controversy over the safety of Sarepta Therapeutics’ gene therapies comes to a head, the biotech is standing firm ...
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Inside the staff exodus and tanking morale that threaten Makary’s FDA
WASHINGTON — The steady erosion of experienced staff at the Food and Drug Administration is slowly compromising the agency’s ...
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HHS Begins Formally Laying Off Employees
Thousands of employees across HHS were terminated Monday evening after the U.S. Supreme Court ruled last week that the Trump ...
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Drug inspectors warn of slower checks following FDA layoffs
Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens ...
Sarepta says it won't comply with FDA request to stop shipping gene therapy Elevidys
U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...
Cambridge pharma company lays off almost 500 amid FDA dispute over treatment
A Massachusetts biotechnology company is laying off nearly 500 employees, more than a third of its total workforce, as it faces pushback from the U.S. Food and Drug Administration on one of its ...
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FDA layoffs could compromise safety of medications made at foreign ...
At the time, the agency said the reductions would not impact inspectors. Kennedy has since announced that HHS would reverse 20% of the cuts across the agency. Amid news reports describing the ...