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

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

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

Despite ongoing debate, medications such as Ozempic continue to rank among the most commonly prescribed treatments for weight ...

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 ...

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 ...

Novo Nordisk has responded to a "warning letter" which claims the pharmaceutical giant didn't report adverse side effects, or deaths, in the required time ...

Officials wrote that Novo Nordisk had failed to failed to report ‘serious and unexpected’ adverse drug experiences ...

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 ...

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

Novo Nordisk faces FDA scrutiny for failing to report Ozempic-linked deaths, highlighting systemic issues in safety reporting ...

Novo Nordisk (NVO) stock dropped 27% YTD after FDA warning letter cited failure to report semaglutide side effects, including three deaths and one suicide.