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Capricor shares sink after US FDA declines approval for cell therapy
The U.S. Food and Drug Administration declined to approve Capricor Therapeutics' cell therapy for a heart condition and asked ...
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 to consider drug affordability when granting new vouchers to speed up approvals, Makary says
It is unclear how the Trump administration will consider affordability when reviewing a drug, as prices are usually ...
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.
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 rejects Capricor’s DMD cell therapy, asks for more data
The FDA has rejected Capricor Therapeutics’ filing for approval of a Duchenne muscular dystrophy (DMD) cell therapy, raising questions about whether the agency's new leadership may be rowing back from ...
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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 ...
FDA Commissioner: ‘We want to focus on food’
“We want to focus on food. People forget that the ‘F’ in FDA stands for food,” Makary said. Makary noted that the processed ...
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 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 ...
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 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 ...