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The U.S. Food and Drug Administration sent a warning letter this month to Novo Nordisk, the maker of Ozempic and Wegovy, ...

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, ...

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

Testing identified significant impurity formation when tirzepatide is compounded with B12 variants, suggesting chemical incompatibility that is not evaluated under FDA review pathways. Uncertainty ...

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

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

WASHINGTON -- The US Food and Drug Administration sent warning letters to Target, Walmart, Kroger and Albertsons after some of the stores failed to remove recalled baby formula linked to a large ...

The FDA slammed ExThera with a warning letter for deviating from the regulatory agency’s guidelines by promoting and selling its Seraph 100 blood filter device to treat cancer patients under specious ...

In the warning letter, the FDA alleged that Novo inadequately responded to observations made after an inspection carried out across January and February of 2025.