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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 ...
FDA Publishes Full Texts of Response Letters to Drug Applications
By Stephanie Brown HealthDay ReporterTHURSDAY, July 10, 2025 (HealthDay News) -- The U.S. Food and Drug Administration has ...
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FDA accepts new supplemental biologics license application for review for Winrevair
The FDA has accepted for priority review a new supplemental biologics license application for Winrevair to treat adults with ...
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 publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration released more than 200 of its so-called complete response letters from its archive on ...
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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FDA’s Rejections: We Read 200 CRLs So You Don’t Have To
A journey through the FDA’s newly released complete response letters gave glimpses into the journeys to market for Eli ...
Palantir founder’s plans for the FDA
Joe Lonsdale, co-founder of the large government contractor Palantir, wants to embed a team of 15 to 20 “elite engineers” ...
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FDA releases ‘initial batch’ of more than 200 drug rejection letters
The FDA has released an “initial batch“ of more than 200 complete response letters (CRLs) in efforts to boost transparency. | ...
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 ...
FDA approves long-acting drug to protect dogs against fleas, ticks
The FDA has approved a long-acting drug to protect dogs against fleas and ticks. The drug, Bravecto Quantum, is given by ...
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FDA advises consumers not to inhale nitrous oxide products
INDIANA- FDA advises consumers not to inhale nitrous oxide products from any size canisters, tanks, or chargers. These ...