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FDA rejects Roche's Columvi in earlier diffuse large B-cell lymphoma, citing lackluster US data
The FDA has declined to approve Columvi, in combination with the chemo regimen GemOx, for the treatment of second-line DLBCL ...
FDA Issues Risk Warning as Apples Recalled in Four States
A recall of thousands of cases of fruits and vegetables has been issued due to potential fluid contamination—the ...
FDA Inspectors Again Find Dangerous Breakdowns at an Indian Factory Supplying Medications to U.S. Consumers
The latest inspection comes 2 1/2 years after the agency allowed Sun Pharma to keep shipping some drugs to Americans even ...
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FDA authorizes Juul e-cigarette device and menthol and tobacco pods
The Food and Drug Administration (FDA) has issued marketing granted orders (MGOs) for Juul e-cigarettes.
FDA lets Juul market vapes in the U.S. three years after trying to ban them
Federal regulators first announced a ban of Juul products in 2022, although a court order allowed them to stay on store ...
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A 'Culture Change' Is Needed in Academic Medicine, FDA Commissioner Says
The culture of academic medicine needs to change, FDA Commissioner Marty Makary, MD, MPH, said at an event sponsored by The ...
FDA to end dozens of 'obsolete' rules for U.S. food items
The U.S. government is nixing a whole slew of "obsolete" U.S. food standards that Trump administration officials say also ...
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FDA grants full approval to Moderna’s Covid vaccine for children but limits eligibility
Moderna’s Covid vaccine for children has been given full FDA approval, making it the first such shot for kids in the U.S.
FDA adds new blue food dye from gardenia fruit
The U.S. Food and Drug Administration on Monday approved the use of a new blue color additive from the gardenia fruit the ...