Tag: FDA
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FDA Giving Fast-Track Review to Alzheimer’s Candidate
U.S. Food and Drug Administration is giving an accelerated review to a candidate drug designed to treat Alzheimer’s disease by reducing the toxicity of amyloid beta proteins making up the plaque accumulating in the brain.
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PhRMA: 258 Vaccines in Clinical Development
An industry group of American pharmaceutical makers says its companies have 258 vaccines, including immunotherapies, in clinical trials or awaiting FDA approval.
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FDA Clears Thin, Transparent Wound Dressing Material
The Food and Drug Administration cleared a new type of thin, transparent wound dressing for marketing in the U.S. as a medical device.
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FDA Funding Brain Tumor Treatment Trial
The biotechnology company DNAtrix is receiving a grant from U.S. Food and Drug Administration to support a clinical trial of its virus-delivered immunotherapy to treat an aggressive form of brain cancer.
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FDA Approves MRI, Ultrasound Device for Tremors
FDA approved for marketing a device that combines ultrasound and MRI to treat essential tremors, a disorder marked by involuntary shaking of the hands.
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Leukemia T-Cell Trial Stopped After Patients’ Deaths
FDA halted a clinical trial testing engineered T-cells as a treatment for leukemia, after 3 participants died. Update: Juno to resume engineered T-cell trial.
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Hundreds of U.S. Clinics Found Selling Stem Cell Services
A comprehensive Internet search finds nearly 600 clinics in the U.S. claiming to offer stem cell treatments, many having dubious scientific or medical validity.
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More Device Approvals, Higher Risks in Europe than U.S.
29 June 2016. An analysis of regulatory approvals and outcomes shows medical devices are reviewed and approved faster in Europe than the U.S., but also face more safety issues later on. A team from Kings College London and Harvard University published its findings yesterday in the journal BMJ. Researchers led by Aaron Kesselheim, a bioethicist…
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FDA Approves Cholera Vaccine
13 June 2016. Food and Drug Administration approved for marketing the U.S. a vaccine to prevent cholera for travelers to regions in the world where contaminated food or water is causing the disease. Vaxchora by PaxVax Inc. in Redwood City, California is the first vaccine approved by the agency to prevent cholera. According to World…
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FDA Clears Insomnia Relief Device
8 June 2016. A device that helps people with insomnia get to sleep without taking drugs received clearance for marketing in the U.S. from the Food and Drug Administration. The device, developed by the company Cerêve in Pittsburgh, Pennsylvania, will require a prescription once it’s on the market in the U.S., expected in the second…