Tag: FDA
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Univ, Industry Labs Study Inhaled Covid-19 Antibodies
Researchers at University of Pennsylvania and Regeneron are studying delivery of synthetic antibodies directly to the nose to prevent Covid-19 infections.
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Trial Requested for Covid-19 Vaccine Nasal Spray
Makers of a Covid-19 vaccine given as a nasal spray asked the Food and Drug Administration to authorize a a human clinical trial of the vaccine.
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Stem Cell Respiratory Therapy Licensed in $1.4B Deal
Global drug maker Novartis is acquiring a stem cell-based treatment for a serious respiratory disease associated with Covid-19 infections.
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FDA Grants Emergency Clearance for Home Covid-19 Test
The Food and Drug Administration gave an emergency authorization for a self-collected Covid-19 diagnostic test, the first such test for home use.
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ALS Stem Cell Therapy Fails to Meet Trial Objective
Clinical trial results of an amyotrophic lateral sclerosis, or ALS, therapy do not show slower disease progression among patients compared to a placebo.
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Covid-19 Saliva Test Earns FDA Emergency Clearance
A test to detect Covid-19 viruses in saliva rather than nasal swabs received emergency authorization from Food and Drug Administration.
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FDA Issues Guidance to Boost Clinical Trial Diversity
Food and Drug Administration issued new regulatory guidance designed to enroll clinical trial participants more representative of the populations they claim to serve.
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FDA to Use Lung Chip Model for Covid-19 Testing
The Food and Drug Administration plans to use organ-on-chip models to test mechanisms for preventing Covid-19 infections, and other processes.
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Process Tests Thousands of Covid-19 Samples at Once
A new technology makes possible simultaneous analysis of diagnostic specimens from thousands of individuals revealing the presence of SARS-CoV-2 coronaviruses.
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FDA Bucks White House, Issues Strict Vaccine Guidance
The U.S. Food and Drug Administration yesterday issued guidance for Covid-19 vaccine developers, requiring extended follow-up with clinical trial participants.