Tag: FDA
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FDA Analyzing Real-World Evidence on Covid-19
The Food and Drug Administration is analyzing collections of health records to gain more evidence-based insights into the course of the Covid-19 pandemic.
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FDA Stops Home Covid-19 Diagnostic Test
The Food and Drug Administration asked designers of a Covid-19 test collecting samples at home for research to stop giving results to individuals.
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Covid-19 Lung Disease Trial Adds Treatments
A clinical trial testing treatments for lung damage in severe Covid-19 cases is adding the anti-viral drug remdesivir and convalescent plasma to its protocol.
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FDA Issues Covid-19 Therapy Trials, Review Guidance
The Food and Drug Administration issued new regulatory guidance on clinical trials and streamlined review processes for Covid-19 treatments.
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Stem Cell Therapy Licensed for Genetic Eye Disease
A biotechnology company is licensing its stem cell treatments for retinitis pigmentosa, an inherited eye disease, in a deal valued at $252 million.
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Biotech Gains Antibody Discovery, Manufacturing Funds
A Canadian biotechnology company is receiving government funds for Covid-19 antibody discovery and manufacturing for current and future pandemics.
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Covid-19 Real-World Evidence System Created
Two health care data science companies are offering a system for assessing proposed treatments from health records data on patients with Covid-19 infections.
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Study Probes Lupus Digital Diagnostics
A company creating diagnostics for autoimmune disorders is beginning a study next month to measure links between its blood-based and digital indicators for lupus.
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FDA Clears Home Covid-19 Diagnostic Test
The Food and Drug Administration today granted an emergency authorization for a Covid-19 diagnostic test performed at home and sent back to a lab.
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Stroke Speech Therapy App Gains Breakthrough Tag
A mobile app providing speech therapy exercises at home for people recovering from a stroke received a breakthrough device designation from FDA.