Marcus A. Banks The US Food and Drug Administration has approved a new catheter designed to treat urinary tract symptoms of an enlarged prostate, also known as benign prostate hyperplasia (BPH). Designed and marketed by Urotronic (Plymouth, Minnesota), the Optilume BPH Catheter System employs mechanical dilation to relieve obstruction of the prostate and then delivers...
Tag: <span>FDA approval</span>
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Tumor-destroying sound waves receive FDA approval for liver treatment in humans
by Jim Lynch, University of Michigan Dr. Alex Duryea, Ph.D., Manager of Applied Research at HistoSonics, adjusts an ultrasound “phantom”—a gel mixed with red blood cells that serves as the test’s tumor—prior to performing a histotripsy treatment demonstration. Credit: Erica Bass, Rogel Cancer Center, Michigan MedicineThe U.S. Food and Drug Administration has approved the use of...
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It’s big-time progress:’ Groundbreaking Alzheimer’s drug soon to gain FDA approval
Updated: Jul. 03, 2023, 1:56 p.m. Published: Jul. 03, 2023, 5:30 a.m. Leqembi, a monoclonal antibody manufactured by Eisai and Biogen, is the first to reduce the amount of amyloid beta plaque in the brain, slowing down the progression of the illness. Though it can’t reverse the damage already done by Alzheimer’s disease, it can produce...
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ALS drug wins FDA approval despite questionable data
by MATTHEW PERRONE Credit: Unsplash/CC0 Public Domain A much-debated drug for Lou Gehrig’s disease won U.S. approval Thursday, a long-sought victory for patients that is likely to renew questions about the scientific rigor behind government reviews of experimental medicines. The Food and Drug Administration approved the drug from Amylyx Pharmaceuticals based on results from one small, mid-stage...
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Lilly wins FDA approval of new kind of diabetes drug
Jonathan Gardner Senior Reporter Eli Lilly & Co. The Food and Drug Administration on Friday approved Eli Lilly’s diabetes drug Mounjaro, a first-of-its-kind treatment that can help control patients’ blood sugar and, potentially, help them lose weight as well. Mounjaro, also known as tirzepatide, expands Lilly’s diabetes business, which includes insulins as well as other...
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HOW A SMALL NEUROTECH STARTUP BEAT ELON MUSK’S NEURALINK TO FDA APPROVAL
Last week, the FDA granted regulatory approval to the neurotech startup Synchron, giving it a groundbreaking go-ahead to conduct more ambitious experiments and test its neural implant in human paralysis patients, setting it on the path to eventually become the first brain implant to get commercial approval. That puts it ahead of Elon Musk’s own neural implant...
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New saliva oral and throat cancer diagnosis test receives FDA approval
by Rose Trapnell, Queensland University of Technology Credit: Queensland University of Technology A QUT researcher’s identification of saliva as an early detection liquid biopsy for oral and throat cancer has been realized by the development and commercialisation of a diagnostic device by US-based biotech company Viome. Viome’s early detection device has been designated a Breakthrough Device...
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A novel pill to treat bleeding from uterine fibroids aims for FDA approval
by Marie McCullough A new drug called elagolix cut blood loss by half over six months in the overwhelming majority of women who participated in two clinical trialspublished Wednesday in the New England Journal of Medicine. Elagolix, being developed by AbbVie, was approved by the U.S. Food and Drug Administration in 2018 under the brand...
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Benlysta approved for children with lupus
(HealthDay)—The intravenous drug Benlysta (belimumab) has been approved by the U.S. Food and Drug Administration to treat children with lupus, a chronic disease that triggers inflammation and damages tissues and organs throughout the body. Approved for adults since 2011, Benlysta is the first lupus treatment in the United States approved for children, the agency said in a news release. “While there is no cure for lupus, treatment can help our youngest...
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‘A loss for the rest of us’: An FDA approval is a boon for a drug maker, but could come at a major cost for patients
Vickie Moored can walk again. Her words don’t slur, her vision isn’t blurred, and she no longer collapses every day. The 65-year-old from Elkton, Va., says she has her life back, thanks to the stunning efficacy of a cheap, but unapproved, chemical called 3,4-DAP. It’s a medication she would not have but for the largesse...
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