Tag: FDA
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Clinical Trials Okayed for Sickle Cell Gene Editing
Two companies developing therapies for inherited blood disorders say the Food and Drug Administration approved their application to begin clinical trials of treatments for sickle cell disease with gene editing.
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FDA Clears A.I. Software Detecting Diabetic Eye Disease
The Food and Drug Administration authorized a system for detecting diabetic retinopathy, a condition threatening the vision of people with diabetes, that uses artificial intelligence to analyze images of patients’ retinas.
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Gene Therapy Biotech Acquired in $8.7 Billion Deal
A biotechnology enterprise developing gene therapies for rare inherited diseases and neurological disorders is being acquired by pharmaceutical company Novartis AG for $8.7 billion.
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FDA Authorizes Interoperable Glucose Monitoring System
The Food and Drug Administration authorized a device that electronically monitors blood glucose levels in people with diabetes, but is also designed to exchange data with other compatible electronic systems.
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High False-Positive Rate Found in Consumer Genetic Tests
Follow-up reviews of results from direct-to-consumer genetic tests show 40 percent of the actionable gene variations reported in the tests, including some indicating disease risk, were erroneous.
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Trials Show Pain Drug Reduces Post-Surgery Opioid Use
Initial results from two late-stage clinical trials show an experimental pain drug with non-opioid ingredients reduces the use of opioid pain relievers following surgery, compared to a placebo and standard care.
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Quick Bacterial Blood Detection Gains Breakthrough Tag
A technology that detects dangerous bacteria in patients’ blood samples in less than an hour received a breakthrough medical device designation from the U.S. Food and Drug Administration.
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FDA Clears Consumer Genetic Breast Cancer Risk Tests
The Food and Drug Administration authorized the first direct-to-consumer tests of genetic risk for cancer, in this case 3 variations of genes associated with higher risk of breast and ovarian cancer.
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Precision Cancer Drug Shown Effective in Adults, Children
Results from 3 clinical trials show most cancer patients given an experimental drug that directly addresses a specific genetic mutation respond to the treatments, despite their cancers occurring in a variety of organs.
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Trial Shows Treatment Desensitizes Peanut Allergies
A large-scale clinical trial shows a preventive treatment desensitizes peanut allergies in children, with most participants able to tolerate substantial amounts of peanut proteins after 1 year.