FDA approves first treatment for rare disease in patients who receive stem cell transplant from blood or bone marrow
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Scritto da Stem Cell Research News From Medical News Today |
The U.S. Food and Drug Administration has approved Defitelio (defibrotide sodium) to treat adults and children who develop hepatic veno-occlusive disease (VOD) with additional kidney or lung... ... ...
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Are stem-cell therapies for parkinson's disease ready for clinical trials
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Scritto da Stem Cell Research News From Medical News Today |
As stem cell-based therapies are moving rapidly towards clinical trials, treatments for Parkinson's Disease (PD), an incurable condition, may be on the horizon. ... ...
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Stem cell therapy enables spinal regrowth
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Scritto da Stem Cell Research News From Medical News Today |
Stem cell treatment on rats with spinal cord injury has led to regeneration of functional tissue that enabled the rats to move their forepaws. ... ...
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Emergency Use Authorizations: Zika Virus RNA Qualitative Real-Time RT-PCR (Focus Diagnostics)
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Scritto da CDRH New |
On April 28, 2016 the FDA issued an Emergency Use Authorization (EUA) to authorize the emergency use of Focus Diagnostics, Inc.'s, Zika Virus RNA Qualitative Real-Time RT-PCR test for the qualitative detection of RNA from Zika virus in human ser ... ...
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Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added)
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Scritto da CDRH New |
Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN150009 added) ... ...
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Notice of Meeting; Establishment of a Public Docket; Request for Comments: June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee
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Scritto da CDRH New |
Notice of Meeting; Establishment of a Public Docket; Request for Comments: June 2-3, 2016 Circulatory System Devices Panel of the Medical Devices Advisory Committee ... ...
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Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Requests for Clinical Laboratory Improvement Amendments Categorization
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Scritto da CDRH New |
The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are required to publish notice in the Federal Register conc ... ...
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