Drugs

Lantheus NDA for Imaging Agent Accepted

FDA has accepted for review a Lantheus NDA for LNTH-2501 (Gallium-68 edotreotide), a diagnostic kit for the preparation of Ga 68 edotreotide injection, indicated for use with positron emission tomography imaging for localization of somatostatin receptor-positive neuroendocrine tumors (NETs) in adult and pediatric patients. Submitted under FDA’s 505(b)(2) pathway, the filing “builds on an extensive evidence base for Ga-68 edotreotide, including multiple published studies,” the company says. The agency has set a user fee review action date of 3/29/2026.

NETs are described as rare, often slow-growing cancers that can develop throughout the body. “Because NETs often grow slowly and cause non-specific symptoms, up to 50% are initially misdiagnosed, leading to delayed detection and treatment,” the company 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