Tag: FDA
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FDA Clears Some Drug Reaction Genetic Tests, Warns About Others
The Food and Drug Administration cleared a consumer genetics company’s tests for gene variations associated with effective or adverse drug reactions, but warned about similar tests from non-authorized providers.
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FDA Preparing Animal, Plant Biotech Regulatory Guidance
The Food and Drug Administration intends to issue new regulatory guidance to cover advances in biotechnology, including genome editing, in animals and plants.
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Diabetes Drug Assessed Long-Term Against All Other Treatments
A new clinical trial is testing the drug semaglutide for people with type 2 diabetes against as many as 40 other diabetes treatments when used as a supplemental drug over 2 years.
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FDA Clears Genomic Bone Marrow Test for Low-Level Cancer
1 Oct. 2018. The Food and Drug Administration on Friday authorized for marketing in the U.S. a system for high-speed analysis of bone marrow samples to find low levels of residual cancer cells. The agency’s announcement cleared the ClonoSeq assay developed by Adaptive Biotechnologies in Seattle to test for minimal residual disease levels in people…
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Liquid Biopsy for Solid Tumors Now Available
A test that inspects a patient’s blood sample for characteristic indicators of solid-tumor cancer, and can be part of a comprehensive precision analytics program, is now on the market.
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Personalized Breast Cancer Trial Advances 7 Drugs
A clinical trial with a design that allows for changes in its processes to meet the needs of individual patients says its results helped advance 7 new drugs for breast cancer into review by FDA.
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Clinical Trial Underway for Lassa Fever Treatment
An early-stage clinical trial is underway to test a treatment for Lassa fever, a viral disease found in West Africa, infecting as many as 300,000 individuals a year.
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FDA to Test New Trial Designs, Assess A.I. Models
FDA plans to pilot test new types of complex clinical trials and is considering a procedure to evaluate machine learning algorithms used in diagnostics.
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FDA Clears Magnetic Device for Obsessive Compulsive Disorder
A non-invasive device using magnetic waves that penetrate the brain to treat obsessive-compulsive disorder received authorization for sales in the U.S. from the Food and Drug Administration.
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FDA Clears Fertility Awareness App for Birth Control
A mobile app for determining a woman’s fertility state on any given day was cleared for marketing in the U.S. as a birth control method.