Biologics

Novo Nordisk Resubmits BLA for Once-Weekly Insulin

Novo Nordisk has resubmitted a BLA for Awiqli (insulin icodec), a once-weekly basal insulin injection for adults with Type 2 diabetes. If approved, the company says Awiqli would become the first once-weekly basal insulin available in the U.S., offering an alternative to daily injections.

The resubmission follows a 7/2024 complete response letter that Novo Nordisk said at the time cited the product’s manufacturing process and a Type 1 diabetes indication. The company says the resubmission is based on data from its ONWARDS Phase 3a program, which enrolled about 4,000 adults with Type 2 diabetes across five randomized, active-controlled trials. The studies compared Awiqli with daily basal insulin, focusing on changes in A1C levels from baseline as the primary endpoint.

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