by BMJ Newswise — In trials, the antipsychotic drug brexpiprazole (Rexulti) failed to provide a clinically meaningful benefit and increased the risk of death. Yet the US Food and Drug Administration (FDA) has fast tracked its approval, making Rexulti the first antipsychotic for treating agitation in elderly patients with dementia. At a cost of around...
Tag: <span>FDA</span>
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FDA Approves First-Ever OTC Erectile Dysfunction Gel
Lisa O’Mary June 13, 2023 A topical gel that may work faster than erectile dysfunction pills has been approved for over-the-counter use in the United States. The gel, which can help users get an erection within 10 minutes, is already available without a prescription in Europe. The FDA approved the drug, called Eroxon, on Friday, noting that it is a first-of-its-kind treatment. Eroxon...
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iLet Bionic Pancreas Cleared by FDA
JUNE 8TH, 2023 CONN HASTINGS MEDICINE The iLet Bionic Pancreas for use by type 1 diabetes patients has been cleared by the FDA and is now available commercially. The device is offered by Beta Bionics, a medtech company based in Massachusetts and California, but the underlying technology originally developed by researchers at Boston University. The system can...
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FDA approves first RSV vaccine, a long-sought scientific achievement
By Helen Branswell May 3, 2023 Reprints KENZO TRIBOUILLARD/AFP VIA GETTY IMAGES The Food and Drug Administration on Wednesday licensed the first-ever vaccine for respiratory syncytial virus, or RSV, completing an elusive quest that has been decades in the making. The product, GSK’s Arexvy, was approved for adults ages 60 and older. GSK beat a crowded field of...
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FDA-Approved At-Home Spirometer: Interview with Charvi Shetty, Co-Founder and CEO at Aluna
OCTOBER 17TH, 2022 CONN HASTINGS CARDIAC SURGERY, CARDIOLOGY, DIAGNOSTICS, EXCLUSIVE, MEDICINE, PEDIATRICS, REHAB, THORACIC SURGERY The COVID-19 pandemic has put lung health firmly in our minds. For those with chronic lung diseases, such as asthma and COPD, an important way to keep track of lung health is to use a spirometer to measure how well...
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FDA change ushers in cheaper, easier-to-get hearing aids
by Tom Murphy Credit: Unsplash/CC0 Public Domain It’s now a lot easier—and cheaper—for many hard-of-hearing Americans to get help. Hearing aids can now be sold without a prescription from a specialist. Over-the-counter, or OTC, hearing aids started hitting the market in October at prices that can be thousands of dollars lower than prescription hearing aids. About 30...
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Supplement manufacturers often ignore FDA warning letters
A considerable proportion of products remain available for purchase after issuance of U.S. Food and Drug Administration warning letters targeting specific supplement products, according to a research letter published in the July 26 issue of the Journal of the American Medical Association. Pieter A. Cohen, M.D., from Cambridge Health Alliance in Somerville, Massachusetts, and colleagues examined...
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FDA approves first treatment for eosinophilic esophagitis
The U.S. Food and Drug Administration (FDA) approved the monoclonal antibody Dupixent (dupilumab) to treat eosinophilic esophagitis patients 12 years and older. The efficacy and safety of Dupixent was evaluated in a randomized, double-blind, parallel-group (Part A and Part B), multicenter, placebo-controlled trial, in which patients received either placebo or Dupixent every week for 24...
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FDA gets over 21,000 medical device reports, including 124 deaths, linked to Philips foam breakdown
Published May 20, 2022 Ricky Zipp Reporter Philips Dive Brief: The Food and Drug Administration released new data about medical device reports associated with Philips Respironics’ ongoing sleep apnea and ventilator recall, including more than 100 cases of patient deaths and tens of thousands of total reports. Between April 2021 and April 30, 2022, the FDA received...
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What Novel Drugs Did the FDA Approve in 2021?
Written by Timothy Aungst, PharmD | Reviewed by Joshua Murdock, PharmD Published on February 17, 2022 Key takeaways: The FDA approved 50 novel (new) drugs in 2021. This is similar to the number of novel drugs approved in 2020. Over half of the novel drugs approved in 2021 were for rare diseases. These are diseases that...