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FDA Commissioner: ‘We want to focus on food’
Makary, a surgical oncologist tapped by President Trump to serve as the the 27th FDA chief, joined NewsNation on Thursday to ...
Capricor Shares Sink After FDA Rejects Drug for Muscle Disease
Capricor Therapeutics Inc. shares plunged more than 60% after US regulators rejected the company’s treatment for a deadly ...
FDA Offers to Trade Faster Drug Reviews for Lower US Prices
Food and Drug Administration Commissioner Marty Makary said his agency may fast-track new drugs from pharmaceutical companies that “equalize” the cost of their medicines between the US and other ...
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Advocates ask for new FDA review of stem cell therapy NurOwn
A coalition of ALS patients and caregivers is petitioning the FDA to review available data on the stem cell therapy NurOwn ...
FDA publishes full texts of response letters to drug applications
The U.S. Food and Drug Administration has published more than 200 complete response letters, or decision letters, sent as ...
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FDA rejects Capricor’s cell therapy for Duchenne muscular dystrophy
The FDA rejected a Duchenne muscular dystrophy cell therapy from Capricor Therapeutics, as a larger study of the treatment ...
FDA gives full approval to Moderna COVID shot for at-risk kids
The Food and Drug Administration (FDA) granted full approval on Thursday to Moderna’s COVID-19 vaccine for children, making it the first COVID shot for kids aged 6 months to 11 years old that is ...
FDA approves 12-month flea treatment for dogs, marking veterinary breakthrough
FDA approves Bravecto Quantum, the first injectable flea and tick treatment offering dogs up to 12 months of protection.
US FDA declines to approve Capricor's muscle disorder therapy
Capricor Therapeutics said on Friday the U.S. Food and Drug Administration has declined to approve its cell therapy deramiocel for a heart condition associated with Duchenne muscular dystrophy.
FDA ends recall of salmonella-contaminated brown eggs
The federal government's investigation into a recall of Salmonella-contaminated brown cage-free and certified-organic eggs ...
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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 ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday published more than 200 of its so-called complete response letters to drugmakers, a significant move to increase transparency of the agency's work.