The U.S. Food and Drug Administration removed a boxed warning about increased risk of leg and foot amputations with Johnson & Johnson’s diabetes drug Invokana.
The U.S. Food and Drug Administration issued a warning letter to Juul Labs Inc. over the company’s marketing practices for e-cigarettes.
The Food and Drug Administration’s new mandatory rules requiring labels on all packaged foods and drinks to indicate the presence of so-called added sugars could have substantial health and cost saving benefits in the United States over the next two decades, a new study suggests.
The U.S. FDA approved two doses of Pfizer Inc.’s medicine Xeljanz for treating active psoriatic arthritis.
The U.S. FDA identified unnamed deficiencies in Antares Pharma’s NDA for Xyosted that halted discussion of labeling and postmarketing requirements.
New Mexico sued eight opioid manufacturers and wholesale distributors, becoming the latest state or local government to file a lawsuit seeking to hold corporations accountable for a national drug addiction epidemic.
(Reuters) – Novo Nordisk will pay nearly $58.7 million to resolve claims the drugmaker’s sales staff downplayed the importance of U.S. Food and Drug Administration-mandated warnings about the cancer risks of its diabetes medication Victoza. The U.S. Justice Department said Tuesday’s settlement would resolve claims Novo Nordisk supplied its sales representatives with information to […]
“As a doctor, father and the head of the U.S. Food & Drug Administration, I believe that everyone is entitled to the information they need to make informed decisions about the food they eat. We serve as the nation’s expert on food labeling, which is why Congress entrusted us with the responsibility of crafting predictable, uniform federal standards that will benefit the health of families across America by ensuring access to essential calorie and nutrition information on food and menu labels.”
Amgen Inc. said the U.S. FDA granted priority review to the company’s request to add important heart safety data to the label of its expensive injectable cholesterol drug Repatha.
Daiichi Sankyo Europe GmbH announced that the European Committee for Medicinal Products for Human Use (CHMP) recommended approval of a label update for the company’s oral, once-daily direct factor Xa-inhibitor Lixiana, to provide guidance on its use in patients undergoing transoesophageal echocardiography (TEE)-guided and delayed cardioversion (treatment to restore a normal heart rhythm).