Tag: FDA
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Gut Tissue From Stem Cells Simulated on Organ Chips
Researchers created working human gut tissue cells derived from stem cells, grown on plastic chips simulating intestinal diseases, as a tool for testing effectiveness and safety of treatments before given to patients.
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Cancer Analytics Company Acquired in $1.9B Deal
The global pharmaceutical company Roche is purchasing the cancer data management and analytics enterprise Flatiron Health in New York for $1.9 billion.
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FDA Clears First Blood Test for Concussions
The Food and Drug Administration authorized for marketing in the U.S. a blood test that screens for chemical indicators in the blood for concussions, a form of traumatic brain injury.
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Report – Industry Pain, Addiction Drug Efforts Flagging
A report by a biotechnology industry organization says development efforts and financing for new drugs to treat pain and addiction are falling behind the health and safety needs of society.
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FDA Approves Wearable Epilepsy Seizure Detector
The U.S. Food and Drug Administration approved a device worn like a wristwatch that uses a machine-learning algorithm to detect convulsive seizures in people with epilepsy.
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Report: 19 New Precision Medicines Approved in 2017
A report on Food and Drug Administration approvals of new therapies says the agency is accelerating its reviews of treatments designed to address the specific molecular composition of individuals.
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Spin-Off Gains FDA Clearance for Bone Graft Material
A company spun-off from a university tissue engineering research lab received clearance from the Food and Drug Administration to market its polymer material in the U.S. to help regrow bones.
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Agencies Send Warnings to Halt Opioid Cessation Scams
Two federal agencies sent warning letters to companies the agencies say are illegally marketing products making false or unsubstantiated claims about their treating opioid addiction or withdrawal.
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FDA to Release More Accessible Clinical Trial Data
The U.S. Food and Drug Administration plans to make available in a more user-friendly format details from clinical trials of new drugs approved by the agency.
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FDA Clears Targeted Breast Cancer Radiation Treatment
The U.S. Food and Drug Administration approved a device that sends high doses of radiation to cancerous breast tissue while sparing healthy tissue nearby.