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FDA approves Novo Nordisk’s oral diabetes drug

The U.S. Food and Drug Administration approved Novo Nordisk’s Rybelsus (semaglutide) tablets 7 mg or 14 mg for adults with type 2 diabetes that along with diet and exercise may improve blood sugar.

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U.S. cases of vaping-related illness rise to 530

U.S. health officials said there are 530 confirmed and probable cases and seven deaths from severe lung-related illnesses tied to vaping, and there are no signs that the outbreak is easing.

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GSK’s over-the-counter nicotine oral spray gets FDA panel backing

An independent expert panel to the U.S. FDA recommended approval of GlaxoSmithKline Plc’s over-the-counter nicotine oral spray that aims to help smokers quit their addiction.

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Erleada Approved for New Prostate Cancer Indication

The U.S. Food and Drug Administration gave the green light to Johnson & Johnson’s Janssen for Erleada (apalutamide) as a treatment for metastatic castration-sensitive prostate cancer.

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Verrica Submits New Drug Application to U.S. FDA

Verrica Pharmaceuticals Inc. submitted a New Drug Application to the U.S. Food and Drug Administration for VP-102 (cantharidin 0.7% topical solution) for the treatment of molluscum contagiosum.

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FDA Approves GSK’s Nucala for Children with Severe Eosinophilic Asthma

The FDA greenlit GlaxoSmithKline’s Nucala (mepolizumab) for treating severe eosinophilic asthma in children as young as 6 years.

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Alfasigma USA Reintroduces IBS-C Drug Zelnorm to U.S. Market

Zelnorm was relaunched by Alfasigma USA for the treatment of irritable bowel syndrome with constipation (IBS-C).

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FDA approves Aspen’s drug to prevent preterm birth

The U.S. Food and Drug Administration approved South African drugmaker Aspen Pharmacare’s hydroxyprogesterone caproate (HPC), which is used to prevent preterm birth in pregnant women.

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Checkpoint Surgical Receives FDA Breakthrough Designation for Nerve Regeneration Device

Checkpoint Surgical Inc. – a leader in hand-held, intraoperative neurostimulation technology for nerve protection and repair – received Breakthrough Device designation from the U.S. Food and Drug Administration for the Checkpoint brief electrostimulation therapy (BEST) system.

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Trump administration seeks ban on flavored e-cigarettes to combat youth addiction

The Trump administration announced plans to remove all flavored e-cigarettes from store shelves in a widening crackdown on vaping, as officials warned that sweet flavors had drawn millions of children into nicotine addiction.

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