Category: Regulations
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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.
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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.
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Current Drug Helps Cut Opioid Use After Surgery
Results from a clinical trial show patients given a current non-opioid pain medication with different types of surgery were less likely to use opioids for up to a year later.
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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.