Category: Regulations
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Nanotech Pancreatic Cancer Immunotherapy Gains FDA Fast Track
The developer of an experimental immunotherapy delivering nanoscale payloads to treat pancreatic cancer says the treatment received fast-track status from the Food and Drug Administration.
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Trial Set to Test Inhaled mRNA for Viral Infections
A developer of messenger RNA therapies for respiratory and rare diseases says it received clearance to begin a clinical trial in the U.K. for an inhaled treatment for viral lung conditions.
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Trial Okayed to Transplant Donated Islet Cells for Type 1 Diabetes
Health authorities in Sweden authorized the start of a clinical trial testing insulin-producing cells from donors engineered to prevent immune reactions in people with type 1 diabetes.
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Keeping Conversations Positive with Precision Moderation
Sponsored content removed due to non-payment.
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Infographic – Little Trust in Companies’ A.I. Use
A poll in the U.S. shows a large majority of Americans who heard of artificial intelligence have very little or no trust that companies will use the technology responsibly.
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Genetic Tests of Breast Cancer Patients Shown Useful
Experiences from a rural hospital in North Carolina show hereditary genetic testing of all breast cancer patients is feasible and can result in changes in care for many patients.
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FDA Funds Study of Real World Data for Biosimilars
A group of managed care organizations is examining the value of real world data from Europe and the U.S. to help FDA review alternative biologic drugs.
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FDA Clears Genetic Cancer Risk Detection Test
The Food and Drug Administration authorized marketing of a genetic test for detecting hundreds of gene variants associated with a higher risk of developing certain cancers.
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FDA Clears Biotech Seasonal Flu Treatment Trial
A start-up biotechnology company says it received the okay for its investigational new drug application of an anti-viral drug to treat a whole class of seasonal flu strains.
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A.I. Mammogram Screening Shown to Improve Cancer Detection
Results of a clinical trial show one radiologist using software with artificial intelligence can detect more breast cancer cases in mammograms than current reviews by two radiologists.