Category: Regulations
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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.
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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.
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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.
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Drug Price Report Calls for Govt Negotiation, More Generics
A panel convened by the National Academies calls for the federal government to use its buying power to negotiate better drug prices for consumers.
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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.
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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.
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Two Opioid Addiction Treatments Found Safe, Effective
A clinical trial testing two leading therapies for opioid abuse found the treatments both safe and effective, even though they work in different ways.
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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.
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Infographic: Largest Hacker Breaches and Regulation Tech
Among the most visible and challenging regulatory issues for companies is security breaches, where companies’ systems are attacked with valuable data stolen.
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FDA Sets Genetic Health Test Review Process
The U.S. Food and Drug Administration is proposing new review requirements for genetic tests of health risks that providers market directly to consumers.