A clinical trial is set to begin that tests a direct form of gene editing with Crispr to correct inherited malfunctioning genes causing sickle cell disease. . . . → Read More: Trial to Test Direct Crispr Blood Stem Cell Edits
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A company developing vaccines delivered through the nose received FDA clearance to begin a clinical trial of its vaccine protecting against Covid-19 infections. . . . → Read More: FDA Clears Covid-19 Nasal Spray/Drops Vaccine Trial  One comment - (Comments are closed)  New products  biomedical, biotechnology, clinical trials, Covid-19, entrepreneurs, FDA, genomics, life sciences, pharmaceuticals, preclinical, university 
Food and Drug Administration granted an emergency authorization for a molecular test for SARS-CoV-2 viruses done at home without a prescription. . . . → Read More: FDA Authorizes Non-Prescription Covid-19 Test Comments are closed Regulations biomedical, clinical trials, Covid-19, engineering, FDA, life sciences, medical device, software 
A home Covid-19 test is being evaluated with a smartphone app, as part of an NIH program to quickly develop Covid-19 diagnostics for widespread use. . . . → Read More: NIH Assessing Home Covid-19 Diagnostic with App One comment - (Comments are closed) New products, Regulations biomedical, challenge, clinical trials, Covid-19, engineering, FDA, life sciences, medical device, NIH, software 
An ALS treatment developer says the Food and Drug Administration advised the company’s clinical trial data would likely not support approval for patient use. . . . → Read More: ALS Trial Results Deemed Insufficient for FDA Approval Comments are closed New products, Regulations biomedical, biotechnology, clinical trials, FDA, life sciences, pharmaceuticals, stem cells 
Food and Drug Administration is updating its regulatory guidance for Covid-19 drugs and diagnostics to cover emerging mutations in the SARS-CoV-2 virus. . . . → Read More: FDA Issues Covid-19 Variant Regulatory Guidance Comments are closed Regulations biomedical, biotechnology, clinical trials, Covid-19, FDA, genomics, life sciences, medical device, pharmaceuticals, preclinical 
A report by a group advocating for precision medicine notes that the Food and Drug Administration approved 20 new personalized drugs and biologics in 2020. . . . → Read More: 20 Precision Meds Approved by FDA in 2020 Comments are closed Regulations biomedical, biotechnology, FDA, genomics, life sciences, medical device, pharmaceuticals 
The Food and Drug Administration granted an emergency authorization for a combination of two synthetic antibodies to treat non-hospitalized Covid-19 infections. . . . → Read More: FDA Clears Covid-19 Dual-Antibody Therapy Comments are closed Regulations biomedical, biotechnology, clinical trials, Covid-19, FDA, life sciences, pharmaceuticals 
The Food and Drug Administration approved a drug regimen given once a month to control HIV infections, to replace daily antiretroviral medications. . . . → Read More: Monthly HIV Drug Combo Approved by FDA One comment - (Comments are closed) New products, Regulations biomedical, FDA, HIV, life sciences, pharmaceuticals 
The U.S. Department of Health and Human Services is buying up to 1.25 million more doses of Regeneron’s Covid-19 antibody therapy, for $2.63 billion. . . . → Read More: US Govt to Buy 1.25M Regeneron Covid-19 Therapies 2 comments - (Comments are closed) Finance, New products biomedical, biotechnology, clinical trials, contract, Covid-19, FDA, life sciences, manufacturing, pharmaceuticals |
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