Tag: FDA
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Nanotech Pancreatic Cancer Immunotherapy Gains FDA Fast Track
The developer of an experimental immunotherapy delivering nanoscale payloads to treat pancreatic cancer says the treatment received fast-track status from the Food and Drug Administration.
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Trial Okayed for Gene-Edited Stem Cell Lupus Treatment
A developer of treatments for cancer and autoimmune disorders from stem cells says FDA cleared its request to start a clinical trial of its therapy for systemic lupus erythematosus.
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Study to Provide Real World Data for A.I. Seizure Forecasts
A developer of medical monitoring systems with data from wearable devices will soon start asking individuals with epilepsy to offer data for an algorithm that predicts seizures.
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Organ Chip Devices to Model for Radiation Sickness
The U.S. government’s health preparedness agency awarded a contract with a university lab to explore organ models on chips to document effects of radiation sickness.
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FDA Funds Study of Real World Data for Biosimilars
A group of managed care organizations is examining the value of real world data from Europe and the U.S. to help FDA review alternative biologic drugs.
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FDA Clears Genetic Cancer Risk Detection Test
The Food and Drug Administration authorized marketing of a genetic test for detecting hundreds of gene variants associated with a higher risk of developing certain cancers.
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FDA Clears Biotech Seasonal Flu Treatment Trial
A start-up biotechnology company says it received the okay for its investigational new drug application of an anti-viral drug to treat a whole class of seasonal flu strains.
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Small Biz Grant Supports Regenerative Alzheimer’s Treatment
A new award from National Institutes of Health funds preclinical work to prepare for a clinical trial assessing a treatment to reverse brain signaling damage in people with Alzheimer’s disease.
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Autoimmune Neuro Disease Start-Up Raises $58M
A new company developing treatments for neurological and psychiatric diseases from aberrant immune system activity is raising $58 million in seed funds.
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FDA Issues Guidance for Opioid Therapy Device Trials
The U.S. Food and Drug Administration issued new regulatory guidance for clinical trials of medical devices designed to prevent or treat opioid use disorder.