Tag: FDA
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FDA Approves Multiple Sclerosis Therapy
The Food and Drug Administration approved a synthetic targeted antibody to treat multiple sclerosis in people with relapsing or steadily worsening forms of the disease.
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Report: More Biotech Regulations Needed, and Soon
A new report from the National Academies calls for a more robust and responsive regulatory system to handle an anticipated flood of biotechnology products.
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Engineered T-Cells Shown Reducing Non-Hodgkin Lymphoma
A clinical trial testing synthetic immune system cells shows after 6 months the cells can generate a full or partial response in many patients with non-Hodgkin lymphoma.
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Trial Begins Testing Enhanced Cord Blood Stem Cells
A clinical trial testing transplant grafts derived from umbilical cord blood as an alternative to bone marrow stem cells for people with blood-related cancers is treating its first patient.
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Biotech Group Withholds Support for Germline Trial Report
A biotechnology industry association in the U.S. says its members are not ready to support recommendations in a new report permitting future clinical studies of genome editing for inheritable disease-causing traits.
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FDA Begins Cancer Product Review Center
The U.S. Food and Drug Administration is reorganizing its review of treatments for cancer into a structure that cuts across its traditional bureaucratic lines.
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Gene Expression Changes Found in Wound Healing Therapy
A clinical trial to reveal the mechanism of a cell therapy to treat venous skin ulcers found the therapy works by altering the gene expression activity of treated cells to resemble healthy tissue.
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Antibody Trials Stopped After Deaths Reported
The U.S. Food and Drug Administration halted early-stage clinical trials of a monoclonal antibody drug for leukemia after four deaths occurred from liver toxicity.
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FDA Approves Spinal Muscular Atrophy Drug [Updated]
A drug to treat spinal muscular atrophy, a genetic disorder causing the wasting away of muscle tissue in children and adults, was approved for sale in the U.S.
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Patent Awarded for Whooping Cough Antibodies
An experimental treatment for pertussis, also known as whooping cough, using engineered humanized antibodies received a patent in the U.S.