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

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, ...

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

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.

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 ...

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

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

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

The Federal Trade Commission (FTC) recently sent warning letters to 10 companies advising them of possible violations of its Consumer Review Rule (the “Rule”), which became effective in 2024 and ...