Drugs

FDA Approves BMS’ Opdualag for Some Melanomas

FDA has approved Bristol Myers Squibb’s Opdualag (nivolumab and relatlimab-rmbw), described as a new, first-in-class, fixed-dose combination of nivolumab and relatlimab, administered as a fixed-dose intravenous infusion, for treating adult and pediatric patients age 12 and older with unresectable or metastatic melanoma. The company says the approval was based on the Phase 2/3 RELATIVITY-047 trial that compared Opdualag to nivolumab alone.

The company says the trial met its primary endpoint of progression-free survival and Opdualag more than doubled the median progression-free survival when compared to nivolumab monotherapy.

The application was approved under FDA’s Real-Time Oncology Review pilot program and also was conducted under the agency’s Project Orbis initiative.

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