Drugs

Panel Backs Novo Nordisk Diabetes Drug

FDA’s Endocrinologic and Metabolic Drugs Advisory Committee has voted 16-0 to recommend approval of Novo Nordisk’s once-weekly semaglutide to improve glycemic control in adults with Type 2 diabetes. In a briefing document released in advance of the meeting, agency reviewers said the indication of semaglutide as an adjunct to diet and exercise to improve glycemic control is supported by efficacy data. “Both doses of semaglutide (0.5 mg and 1.0 mg) demonstrated superiority to placebo, in terms of change in HbA1c from baseline, in a monotherapy trial as well as in atrial with basal insulin background therapy (Table 6),” FDA reviewers noted. “Both doses of semaglutide also demonstrated superiority to active comparators sitagliptin and insulin glargine for the HbA1c primary endpoint. Semaglutide 1.0 mg also demonstrated superiority to exenatide ER.”

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome