Drugs

FDA Extends Review of Lantheus PET Imaging Agent

FDA has extended by three months its review of a Lantheus Holdings’ NDA for LNTH-2501, a diagnostic imaging agent targeting neuroendocrine tumors, pushing the decision date to 6/29. The review extension will allow the agency additional time to evaluate new manufacturing-related information submitted by the company. Lantheus emphasized that the delay is not related to any concerns about the drug’s safety or efficacy.

According to the company, FDA requested more time to complete its assessment after receiving additional data tied to manufacturing processes. Such extensions are relatively common when regulators need to fully review late-cycle submissions.

LNTH-2501 (gallium-68 edotreotide) is a positron emission tomography imaging kit designed to help detect somatostatin receptor-positive neuroendocrine tumors (NETs) in both adult and pediatric patients. The product is supplied as a two-vial kit that allows radiopharmacies to prepare the imaging agent on-site using a gallium generator.

If approved, the imaging agent would support clinicians in localizing NETs by binding to somatostatin receptors, which are commonly overexpressed in these tumors, according to the company. PET imaging plays a critical role in diagnosing and managing NETs, including staging and monitoring disease progression.

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