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Pfizer’s Xeljanz Gets FDA Nod As Joint Disease Treatment

The U.S. FDA approved two doses of Pfizer Inc.’s medicine Xeljanz for treating active psoriatic arthritis.

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FDA Responds to Antares Pharma’s Xyosted NDA

The U.S. FDA identified unnamed deficiencies in Antares Pharma’s NDA for Xyosted that halted discussion of labeling and postmarketing requirements.

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New Mexico sues opioid drug manufacturers, distributors

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.

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Novo Nordisk settles U.S. probe over diabetes drug for nearly $58.7 million

  (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 […]

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Statement from FDA Commissioner Scott Gottlieb, M.D., on the FDA’s role in ensuring Americans have access to clear and consistent calorie and nutrition information

“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.”

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Amgen gets fast FDA review for adding heart benefits to cholesterol drug label

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.

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CHMP Issues a Positive Opinion for Daiichi Sankyo’s Once-Daily Lixiana in Patients with Atrial Fibrillation Undergoing Cardioversion

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).

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Novartis receives EU approval for Cosentyx label update

Novartis said the Committee for Medicinal Products for Human Use approved a label update for Cosentyx (secukinumab), the first interleukin-17A approved to treat psoriasis.

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FDA delays rolling out new nutrition facts label

The U.S. Food and Drug Administration delayed indefinitely implementation of a new nutrition facts label that would enlarge calorie counts, itemize added sugar and bring serving sizes in line with actual average portions.

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J&J diabetes drug shows heart benefit in large safety study

Johnson & Johnson’s type 2 diabetes drug Invokana significantly reduced the risk of serious heart problems in patients with established heart disease or at elevated risk in a pair of large studies, according to data presented at a medical meeting.

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