Almost five years since the pandemic began, there is not a single FDA-approved treatment An installation of 300 cots in front of the Washington Monument on May 12, 2023, representing the millions of people suffering from long Covid and myalgic encephalomyelitis/chronic fatigue syndrome.Andrew Harnik/AP By Julia Moore Vogel and Charlie McCone Oct. 24, 2024 Moore Vogel is a...
Tag: <span>FDA approval</span>
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FDA says compounding pharmacies can keep making weight-loss med tirzepatide, for now
Pharmacists may continue making compounded versions of the weight-loss medication tirzepatide while the U.S. Food and Drug Administration revisits its Oct. 2 decision to remove the medicine from a national drug shortage list. What prompted the FDA to reconsider its decision? On Oct. 7, a compounding trade group filed a lawsuit challenging the agency’s action, saying there was...
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FDA approves Hympavzi for hemophilia
The U.S. Food and Drug Administration (FDA) approved Hympavzi (marstacimab-hncq) for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in adult and pediatric patients aged 12 years and older with hemophilia A without factor VIII inhibitors or hemophilia B without factor IX inhibitors. Unlike other drugs that replace a clotting factor, Hympavzi is...
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FDA Approves New Device for Enlarged Prostate Treatment
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...
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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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