Drugs

Breakthrough Status for Mortality Prognosticator Tool

FDA has granted Onc.AI a breakthrough device designation for its Serial CT Response Score (Serial CTRS) AI model, which the company describes as an artificial intelligence (AI)-based prognostic tool that uses deep learning to analyze CT scans and stratify lung cancer patients into high- or low-mortality risk categories. The designation is based on data demonstrating that Serial CTRS improved the prediction of overall survival for patients receiving immunotherapy compared to traditional imaging assessment tools, the company says.

Onc.AI says the AI model is also being evaluated for use in oncology drug development programs. “Notably, it has demonstrated outperformance of the standard RECIST 1.1 in predicting overall survival, paving the way for superior decision-making in trial design and clinical development decisions for novel oncology therapeutics,” it says. RECIST 1.1 is described as the most widely used method for evaluating tumor response in clinical trials.

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