The FDA issued a warning letter to Novo Nordisk, the Danish drugmaker behind the diabetes and weight-loss medications Ozempic and Wegovy, over unreported potential side effects.
The FDA issued a warning letter to Novo Nordisk — the maker of Ozempic and Wegovy — for failing to report potential side effects in patients who took its blockbuster medications.
COPENHAGEN, March 10 (Reuters) - Novo Nordisk said on Tuesday it had received a warning letter from the U.S. Food and Drug Administration regarding an inspection at the Danish drugmaker's site in ...
Novo Nordisk announced receiving a warning letter from the FDA following an inspection at its Plainsboro site. The company has devised a corrective action plan, keeping the FDA informed. Novo Nordisk ...
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 ...
Novo Nordisk received a warning letter from the FDA regarding an inspection at its New Jersey site in early 2025. The company has initiated a corrective action plan, continuously updating the FDA.
The FDA inspected the Danish manufacturer in January and February 2025 and found that it did not comply with adverse event reporting regulations. medication approval holders must have documented ...
THE Food and Drug Administration (FDA) vowed Sunday, February 22, 2026, to continue inspecting establishments to ensure ...
The FDA is stepping up its unannounced inspections of foreign manufacturing facilities. In a statement about the increase in inspections, the Food and Drug Administration did not report how many ...
On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...
Hyderabad: Aurobindo Pharma Limited on February 27, 2026 announced the completion of a US FDA inspection at Unit I of its wholly owned subsidiary Eugia Pharma Specialities Ltd. The inspection, ...