Drugs

GE’s DaTscan Expanded Dementia Use OK’d

FDA has approved an expanded use for GE Healthcare’s DaTscan (ioflupane I 123 injection) for use in patients with suspected dementia with Lewy Bodies (DLB). Previously, the radiopharmaceutical was approved for use with single photon emission computed tomography (SPECT) imaging to visualize dopamine transporters (DaT) in the brains of adult patients with suspected Parkinsonian syndromes.

“The clinical signs and symptoms of DLB can be atypical and overlap with other forms of dementia, leading to up to 70% of patients with DLB being misdiagnosed, often as having Alzheimer’s Disease,” the company says. This new indication is intended to enable clinicians to use DaTscan to help differentiate DLB from other forms of dementia.

Earlier this year, GE said it planned to improve its molecular imaging neurology portfolio by complementing DaTscan with two pipeline radiopharmaceuticals, one for Positron Emission Tomography (PET) and another for SPECT, “aiming to offer customers, in both clinical and research settings, a wider choice of diagnostic tracers to help evaluate adult patients with suspected Parkinsonian syndromes.”

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