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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

FDA to Test New Trial Designs, Assess A.I. Models

Scott Gottlieb

FDA plans to pilot test new types of complex clinical trials and is considering a procedure to evaluate machine learning algorithms used in diagnostics. . . . → Read More: FDA to Test New Trial Designs, Assess A.I. Models

FDA Clears Magnetic Device for Obsessive Compulsive Disorder

brain stimulationgraphic

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. . . . → Read More: FDA Clears Magnetic Device for Obsessive Compulsive Disorder

FDA Clears Fertility Awareness App for Birth Control

Natural Cycles app and device

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. . . . → Read More: FDA Clears Fertility Awareness App for Birth Control

FDA Approves RNA-Interference Nerve Disease Therapy

Onpattro

A treatment that silences the actions of RNA and reverses damage to nerves from a rare inherited neurological disease was approved by the Food and Drug Administration. . . . → Read More: FDA Approves RNA-Interference Nerve Disease Therapy

FDA Issues Draft Gene Therapy Regulatory Guidance

Editing DNA

FDA issued a series of draft documents spelling out its processes for reviewing gene therapies for three types of diseases, as well as producing and testing these treatments. . . . → Read More: FDA Issues Draft Gene Therapy Regulatory Guidance

FDA Reviewers Found Accepting Industry Payments After Drug Approvals

Pills and dollars

A new report finds a large percentage of panel members that review drug applications for the Food and Drug Administration accept payments and other rewards from companies after their drugs are approved. . . . → Read More: FDA Reviewers Found Accepting Industry Payments After Drug Approvals