Tag: FDA
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FDA Approves Gene Therapy for Inherited Vision Loss
A therapy using transfers of healthy genes to treat a rare form of inherited vision loss was approved today by the U.S. Food and Drug Administration.
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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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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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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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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.
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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.
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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.