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US FDA declines to approve Ultragenyx's gene therapy for rare inherited disorder
The U.S. Food and Drug Administration has declined to approve Ultragenyx Pharmaceutical's experimental gene therapy to treat ...
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 Issues Risk Warning for Sunscreen Recall in Multiple States
Class II recalls from the FDA indicate a potential risk to consumer safety where use or exposure to the product may cause ...
Senate panel clears FDA appropriations
Presented by Express Scripts Pharmacy Benefit Services{beacon} Health Care Health Care   The Big Story Senate panel clears ...
FDA fully approves Moderna's COVID vaccine for some young kids
Moderna's COVID-19 vaccine has received full approval from the U.S. Food and Drug Administration (FDA) for use in children ...
Blockbuster long acting flea and tick treatment for dogs coming after FDA approval
A long-acting flea and tick treatment from Merck Animal Health has earned approval for dogs at least six months old from the Food and Drug Administration (FDA).
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 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 ...
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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 ...
Recall alert: FDA warns against eating these chocolate products
The FDA is urging customers with a milk allergy to avoid consuming the recalled chocolate products. Customers can also return the products to where they were purchased for a full refund, according to ...
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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 ...