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STAT+: Obesity drug Wegovy gets FDA approval to add cardiovascular benefits on its label

STAT

regulators approved a label expansion for Novo Nordisk’s obesity drug Wegovy to tout its benefits for the heart, a move that could boost demand and insurance coverage for the already highly popular treatment. Novo said it has also filed for a label expansion in Europe and a decision is expected this year.

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STAT+: FDA alters warning label for Carvykti CAR-T, although link to secondary cancers is unclear

STAT

The Food and Drug Administration issued a change to the warning label for Legend Biotech and Janssen’s myeloma CAR-T, Carvykti or cilta-cel, adding that some secondary blood cancers have occurred following treatment for multiple myeloma with the cell therapy. 

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STAT+: The FDA is testing new nutrition labels on the front of food packages

STAT

Much of the Americas already has so-called front of package labels — small symbols printed on packaged foods that alert consumers when a food is high in certain unhealthy nutrients like sodium or saturated fat. Now, the Food and Drug Administration is embarking on a major study to test front of package labels here in the U.S.,

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STAT+: Solicitor general urges Supreme Court to review ‘skinny labeling’ and generic drug access

STAT

Supreme Court to review a controversy over so-called skinny labels for medicines, arguing that an appeals court finding threatens the availability of lower-cost generic drugs. solicitor general urged the U.S.

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Kellogg’s is going to war over Mexico’s nutrition label rules. A similar fight is coming to the U.S.

STAT

A 2019 policy requires companies that make unhealthy foods to include warning labels on the front of any boxes they sell in Mexico to educate consumers about things like excess sugar and fat. MEXICO CITY — Kellogg’s is waging a war here over Tigre Toño and Sam el Tucán.

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National Academies calls for transforming use of racial and ethnic labels in genetics research

STAT

Saying genetics researchers inconsistently and inappropriately use racial and ethnic labels that fail to capture the complex patterns of human genetic variation, the National Academies of Sciences, Engineering, and Medicine issued a report Tuesday calling for a transformation in how such descriptors are used.

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STAT+: U.S. Supreme Court declines bid by Teva to hear ‘skinny labeling’ case with implications for generic drug access

STAT

At issue is skinny labeling, which happens when a generic company seeks regulatory approval to market its medicine for a specific use, but not other patented uses for which a brand-name drug is prescribed. And skinny labeling, which amounts to a carve-out, is one way that Congress attempted to foster more competition to benefit consumers.

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