Drugs

FDA Approves Lilly Interchangeable Insulin Product

FDA has approved Lilly’s Rezvoglar (insulin glargine-aglr) as an interchangeable biosimilar insulin product to Sanofi’s Lantus (insulin glargine). The agency says Rezvoglar is a long-acting human insulin analog indicated to approve glycemic control in adults and pediatric patients with diabetes mellitus. FDA previously approved Rezvoglar as a Lantus biosimilar on 12/17/21.

Interchangeable biosimilars have met additional requirements so they may be substituted for the reference product at the pharmacy if state laws permit, FDA says. Rezvoglar is available in 3 mL prefilled pens and is administered subcutaneously once daily. It joins Mylan’s Semglee (insulin glargine-yfgn) as an interchangeable biosimilar insulin.

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