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FDA Issues Draft Precision Medicine Trial Guidance

The U.S. Food and Drug Administration issued draft regulatory guidance on clinical trials for new treatments that target genetic mutations rather than disease states. . . . → Read More: FDA Issues Draft Precision Medicine Trial Guidance

FDA Fast-Tracks Heart Failure Gene Therapy

A biotechnology company developing transfers of healthy genes to treat chronic diseases is receiving an accelerated review of its heart failure therapy from the U.S. Food and Drug Administration. . . . → Read More: FDA Fast-Tracks Heart Failure Gene Therapy

CAR T-Cells Shown Effective in Long-Term Studies

Results from two clinical studies of engineered immune system cells show patients continue to respond their treatments after 6 months or more. . . . → Read More: CAR T-Cells Shown Effective in Long-Term Studies

PTSD Drug Trial Begins, Gets Fast-Track Status

An experimental drug that aims to keep nerve cells flexible is beginning an early-stage clinical trial as a treatment for post-traumatic stress disorder, or PTSD. . . . → Read More: PTSD Drug Trial Begins, Gets Fast-Track Status

FDA Approves Precision Solid Tumor Cancer Diagnostics

The Food and Drug Administration approved genomic tests for solid tumor cancers that identify the most promising available therapies matched to the tumor’s genetic mutations. . . . → Read More: FDA Approves Precision Solid Tumor Cancer Diagnostics

FDA Clears Smart Watch EKG Device

The Food and Drug Administration approved an electrocardiogram, or EKG device, designed to work with Apple smart watches, according to AliveCor, developer of the device. . . . → Read More: FDA Clears Smart Watch EKG Device

Trial to Test Ultrasound/MRI for Brain Cancer

A developer of a technology that combines ultrasound and MRI scans plans to begin a clinical trial of its techniques to improve delivery of drugs to treat a form of brain cancer. . . . → Read More: Trial to Test Ultrasound/MRI for Brain Cancer

Biotech, Cancer Center Partner on T-Cell Research

A developer of cancer diagnostics and treatments is collaborating with Moffitt Cancer Center to advance therapies for ovarian cancer with T-cells from the immune system. . . . → Read More: Biotech, Cancer Center Partner on T-Cell Research

Report: Health System Not Ready for Alzheimer’s Therapies

A new study finds the U.S. health care system does not have the capacity for large-scale screening and treatment of people with early indicators of Alzheimer’s disease. . . . → Read More: Report: Health System Not Ready for Alzheimer’s Therapies

FDA Clears First Sensor-Pill and App System

The Food and Drug Administration approved for the first time in the U.S. a system that combines pills with built-in sensors and a mobile app to track adherence. . . . → Read More: FDA Clears First Sensor-Pill and App System