Drugs

Avid Radiopharm Alzheimer’s Imaging Drug Approved

FDA has approved an Avid Radiopharmaceuticals NDA for Tauvid (flortaucipir F18) for intravenous injection, the first drug for helping image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. The radioactive diagnostic agent is intended for adult patients with cognitive impairment who are being evaluated for Alzheimer’s. It is indicated for positron emission tomography brain imaging to estimate the density and distribution of aggregated tau neurofibrillary tangles, a primary marker of Alzheimer’s disease, according to an agency release.

Approval was based on data from two clinical studies. In each study, five evaluators, who were blinded to clinical information, interpreted the imaging as positive or negative, according to the agency. Data showed that the evaluators reading the Tauvid images had a “high probability of correctly evaluating patients with tau pathology and had an average-to-high probability of correctly evaluating patients without tau pathology,” it says. “Tauvid’s ability to detect tau pathology was assessed in patients with generally severe stages of dementia and may be lower in patients in earlier stages of cognitive decline than in the patients with terminal illness who were studied.”

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