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 ...

Novo Nordisk issued a response to an FDA warning letter that cited serious violations in how the company tracked and reported ...

The FDA has issued a warning letter to Novo Nordisk for violating postmarketing adverse drug experience regulations that include failure to report adverse events among patients taking GLP-1s. In the ...

The Food and Drug Administration sent a warning letter to the makers of Ozempic and Wegovy for not reporting potential side ...

Among the unreported adverse events potentially linked to Ozempic are two deaths and one case of “completed suicide,” according to an FDA inspection report.

The U.S. Food and Drug Administration (FDA) has issued a warning to Novo Nordisk over its alleged failure to report adverse side effects, including death, in patients who took its GLP-1 medications, ...

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 ...

The FDA has issued warnings to 30 telehealth companies for making false or misleading claims regarding compounded GLP-1 ...

COPENHAGEN, March 10 (Reuters) - Novo Nordisk said on Tuesday it had received a warning letter from the U.S. Food and Drug ...

Amid the company’s efforts to resolve issues raised during an FDA inspection early last year, Novo Nordisk’s operating base in Plainsboro, New Jersey—already the recipient of a recent Form 483—has ...