Heath Secretary Robert F. Kennedy Jr.’s efforts to overhaul vaccine policy are likely illegal, a Massachusetts District Court Judge ruled; Structure’s GLP-1 weight loss pill succeeds in Phase 2 while ...

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Novo Nordisk's reports to the FDA spiked shortly after an inspection found the Ozempic producer ignored reports of deaths and potential side effects.

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not posted for public view until weeks or months ...

The Palm Beach Police's use of donated LifeVac anti-choking devices follows the FDA's recent approval of them as backup ...

Federal regulators have warned the maker of Ozempic and Wegovy that it failed to report possible drug side effects to the ...

Novo Nordisk is facing scrutiny from U.S. regulators after concerns were raised about how the company reported potential side effects linked to its semaglutide medicines.

Simtra BioPharma Solutions was issued a warning letter by the FDA after an inspection uncovered a number of problems at the ...

The FDA sent a warning letter this month to Novo Nordisk, alleging the drugmaker failed to report, in a timely manner, potential side effects in patients who took its popular medications containing ...

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Novo Nordisk — the pharmaceutical giant behind GLP-1 medications like Ozempic and Wegovy — has received a warning letter from the U.S. Food and Drug Administration, for “serious violations” of the age ...

The agency says the Ozempic and Wegovy maker failed to properly investigate and report serious adverse events, including ...