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Trial Shows Treatment Prevents Peanut Allergy Reactions

Peanutes in shells

Final results from a clinical trial show a preventive treatment desensitizes children and adolescents with peanut allergies against reaction-causing proteins in peanuts for one year. . . . → Read More: Trial Shows Treatment Prevents Peanut Allergy Reactions

Survey Shows Sharp Rise in Teen E-Cigarette Use

Juul e-cigarette

New data from a continuing survey of smoking among school-age children shows large increases in electronic cigarette use in high school and middle school children in just the past year. . . . → Read More: Survey Shows Sharp Rise in Teen E-Cigarette Use

FDA Updating Expanded Access to Investigational Drugs, Devices

Scott Gottlieb

The Food and Drug Administration says it’s streamlining policies for making drugs and medical devices in clinical trials or under review available for people in the U.S. with life-threatening conditions. . . . → Read More: FDA Updating Expanded Access to Investigational Drugs, Devices

FDA Clears Some Drug Reaction Genetic Tests, Warns About Others

DNAmolcule model

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. . . . → Read More: FDA Clears Some Drug Reaction Genetic Tests, Warns About Others

FDA Preparing Animal, Plant Biotech Regulatory Guidance

Two piglets

The Food and Drug Administration intends to issue new regulatory guidance to cover advances in biotechnology, including genome editing, in animals and plants. . . . → Read More: FDA Preparing Animal, Plant Biotech Regulatory Guidance

Diabetes Drug Assessed Long-Term Against All Other Treatments

Bathroom scale

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. . . . → Read More: Diabetes Drug Assessed Long-Term Against All Other Treatments

FDA Clears Genomic Bone Marrow Test for Low-Level Cancer

Detect cancer scrabble

(Marco Verch, Flickr)

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 . . . → Read More: FDA Clears Genomic Bone Marrow Test for Low-Level Cancer

Liquid Biopsy for Solid Tumors Now Available

Blood sample tubes

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. . . . → Read More: Liquid Biopsy for Solid Tumors Now Available

Personalized Breast Cancer Trial Advances 7 Drugs

Laura Esserman

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. . . . → Read More: Personalized Breast Cancer Trial Advances 7 Drugs

Clinical Trial Underway for Lassa Fever Treatment

Lassa fever investigation

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. . . . → Read More: Clinical Trial Underway for Lassa Fever Treatment