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That Dairy Queen cone that’s cooling you off can’t legally be called ‘ice cream,’ FDA says — here’s why
Though the regulations and labeling changed, Dairy Queen’s recipe never did. Now Dairy Queen’s soft serve qualifies as ...
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FDA Advisory Panel Votes Against Approval of GSK's Blenrep Combo
GSK plc GSK announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted against the overall benefit/risk ...
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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 ...
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 ...
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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 patients who are not eligible for autologous stem cell transplant, Roche ...
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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 include "unnecessary" ones.
F.D.A. Approves Juul Vapes After Yearslong Delay
The Food and Drug Administration authorized Juul e-cigarettes for the U.S. market on Thursday, ending a lengthy standoff with ...
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Myeloma Drug's Comeback Nixed by FDA Panel
The comeback story of belantamab mafodotin (Blenrep) hit a roadblock Thursday as the FDA's Oncologic Drugs Advisory Committee ...