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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 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 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 for more data, the drugmaker said on Friday, sending its shares 40% lower ...
Ritz Crackers Recalled by FDA Due to Undeclared Allergen
Several bulk boxes of Ritz cracker sandwich sleeves were recalled by their manufacturer and the FDA. Some peanut ...
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Pharmalittle: We’re reading about a FDA offer on drug reviews, a Moderna Covid approval, and more
FDA head Marty Makary said the agency may fast-track drugs from companies that “equalize” the cost of medicines between the U ...
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.
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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 ...
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FDA turns back Capricor’s Duchenne cell therapy
The company said it was “surprised” by the decision, which followed the ouster of multiple cell and gene therapy officials from the agency during deramiocel’s review.
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 ...
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 ...
US FDA publishes 200 complete response letters from archive in transparency drive
The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency ...