Drugs

FDA Approves Updated Label for Lilly’s Trulicity

FDA has approved an updated label for Eli Lilly’s once-weekly Trulicity (dulaglutide) to include use in combination with basal insulin for adults with Type 2 diabetes. Trulicity is a once-weekly glucagon-like peptide-1 receptor agonist injectable prescription medicine designed to improve blood sugar (glucose) in adults with Type 2 diabetes. The product is available in a prefilled pen in 0.75 and 1.5 mg doses.

The label update is based on FDA review of results from the AWARD-9 clinical trial, a Phase 3b, randomized, double-blind, placebo-controlled, 28-week study that evaluated the efficacy and safety of once-weekly Trulicity 1.5 mg as an add-on to titrated insulin glargine, with or without metformin, compared to placebo as an add-on to titrated insulin glargine, with or without metformin, according to the company. “Study results showed that Trulicity 1.5 mg significantly reduced A1C as an add-on to insulin glargine (1.4%) after 28 weeks compared to placebo plus insulin glargine (0.7%),” it says.

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