Drugs

FDA OKs Iron-Based MRI Contrast Agent

FDA has approved Azurity Pharmaceuticals’ Ferabright (ferumoxytol injection), an iron-based contrast agent for magnetic resonance imaging (MRI) of the brain in adults with known or suspected malignant brain tumors. The product is designed to help radiologists visualize lesions with a disrupted blood-brain barrier, enhancing the detection and delineation of both primary and metastatic brain neoplasms, according to the company.

Azurity says approval is based on data from a pivotal clinical study, which showed that a Ferabright-enhanced MRI significantly improved visualization of brain tumors compared with pre-contrast imaging. The drug’s extended imaging window, resulting from its long half-life, may allow for more flexible MRI scheduling and potentially reduce the need for repeat contrast administration, the company says.

Because Ferabright is iron-based, it is processed through the body’s natural iron metabolism pathways — potentially minimizing the long-term tissue retention risks associated with gadolinium-based agents, the company says. The drug is also suitable for patients with renal insufficiency, providing an option for those who cannot safely receive other MRI contrast materials.

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