Category: Regulations
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FDA Clears Artificial Pancreas System for Type 1 Diabetes
The Food and Drug Administration cleared for sale a system that automatically monitors blood glucose and maintains basic insulin levels in people with type 1 diabetes.
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Trial Shows Engineered T-Cells Can Stop Lymphoma
Early results of a clinical trial show an individual’s own immune system cells altered to attack non-Hodgkin lymphoma can cause a partial or complete response in a large percentage of patients.
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Antibiotic Shown to Control Drug-Resistant Gonorrhea
Findings from a clinical trial show a candidate drug kills bacteria causing a type of gonorrhea becoming resistant to current antibiotics.
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Clinical Trial Testing Live Bacteria as Acne Treatment
A clinical trial is recruiting participants to test a product with live skin bacteria made by biotechnology company AOBiome as a treatment for adult acne.
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Drug Shown to Improve Cell Energy, Muscle Function
Results of a clinical trial show an experimental drug by Stealth BioTherapeutics boosts cellular energy and improves skeletal muscle functions of older adults.
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Stem Cells Aid Motor Functions in Spinal Cord Patients
First results from a clinical trial show stem cell treatments help restore some arm and hand functioning in patients with complete cervical spinal cord injury.
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Trial Testing Diabetes Drug as Parkinson’s Treatment
A clinical trial has started to test a current drug for type 2 diabetes as a treatment for Parkinson’s disease.
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Orphan Status Granted for Hemophilia Genome Editing
Treatments using genome-editing techniques for hemophilia B, a rare blood clotting disease, received orphan therapy status from the U.S. Food and Drug Administration.
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Trial Shows Antibody Slows Alzheimer’s Cognitive Decline
A clinical trial shows older individuals with early or mild cases of Alzheimer’s disease treated for a year with an engineered human antibody have less decline in mental functions associated with Alzheimer’s disease.
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FDA Giving Fast-Track Review to Alzheimer’s Candidate
U.S. Food and Drug Administration is giving an accelerated review to a candidate drug designed to treat Alzheimer’s disease by reducing the toxicity of amyloid beta proteins making up the plaque accumulating in the brain.