Tag: FDA
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Engineered T-Cell Trial Halted After Participant Dies
A clinical trial testing treatments that modify immune system cells to fight leukemia in adults was stopped after one of the patients died from inflammation in the brain.
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Targeted Leukemia Drugs Sharply Raising Costs of Care
Drugs directly attacking cancer cell growth show high remission rates with a common form of leukemia, but a new study suggests the high costs of these drugs could impose difficult economic burdens on patients and the health care system.
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Long-Acting Opioid Abuse Therapy Shown Working in Trial
An experimental long-acting drug was shown at least as effective, and in some cases superior, to the current standard of care for opioid use disorder.
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Florida Voters Give Split Decision on GM Mosquitoes [Updated]
Voters in the Florida Keys yesterday returned a split decision on non-binding ballot questions about testing genetically modified mosquitoes to stop the Zika virus.
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Institutes, Companies Form Business to Bridge Discovery Gap
Three research institutions with pharmaceutical and venture capital companies are creating a new enterprise to fill the drug development gap between proof-of-concept and initial clinical trials.
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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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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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FDA Holding Opioid Overdose App Competition
The U.S. Food and Drug Administration is seeking a smartphone app that can quickly find a source of the antidote drug naloxone for someone having an opioid overdose.
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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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Takeda Awarded $19.8 Million for Zika Vaccine
Takeda Pharmaceutical Company is receiving $19.8 million from a U.S. public health agency for initial steps to develop a vaccine to prevent Zika infections.