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Workshop on Devices to Treat Obesity

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Federal Register Notice: FDA plans a public workshop 12/19-20 on developing medical devices to treat morbid obesity and other meta...

Metformin Helps Cancer Patients with Diabetes: Study

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Researchers say that cancer patients with concurrent diabetes benefit significantly from treatment with metformin in terms of over...

California Federal Court Dismisses Biosimilar Case

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A federal judge dismisses a Sandoz biosimilar patent complaint over Enbrel for lack of jurisdiction.

Safety Labeling Changes Include Oral Contraceptives Boxed Warning

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FDA approves safety labeling changes for 68 drugs, including a Boxed Warning for five oral contraceptives.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Avacen Inc., Luis Dairy, and Northwest Veterinary Associates.

Multiple Violations Found in Avacen Inspection

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FDAs Los Angeles District Office warns Avacen about Quality System Regulation violations in its manufacturing of the Avacen Therma...

FDA Urged: Dont Impose Pregnancy Opioid Label Changes

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National Advocates for Pregnant Women petitions FDA not to implement its neonatal opioid withdrawal syndrome-related safety labeli...

New Boxed Warning for Immune Globulin Products

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FDA announces addition of a Boxed Warning and other labeling changes for human immune globulin products.

FDA Approves Pfizer sNDA for Arthritis Drug

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FDA approves a Pfizer supplemental NDA for its arthritis drug Xeljanz (tofacitinib citrate) to include additional patient-reported...

FDA Accepts AstraZeneca NDA for Naloxegol

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FDA accepts an AstraZeneca NDA for naloxegol, an investigational peripherally-acting mu-opioid receptor antagonist, indicated for ...