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
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A single diagnostic test for the virus causing Covid-19 infections and three other respiratory diseases received clearance for marketing in Europe. . . . → Read More: Diagnostic Cleared for Covid-19, Other Diseases 
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 
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 
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 
Biden’s vaccine distribution team needs to find those doses, and fast, before their shelf life expires. . . . → Read More: Essay – Find the Missing Vaccine Doses One comment - (Comments are closed) New products, Regulations biomedical, Covid-19, economics, manufacturing, pharmaceuticals, software, special 
Wearing a face mask has become a hot-button public controversy in the U.S., but a continuing survey shows Americans by and large are wearing masks in public. . . . → Read More: Infographic – Most Americans Wearing Mask in Public 
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. Food and Drug Administration issued draft administrative and procedural guidelines for genetic disorders treated with precise gene therapies. . . . → Read More: FDA Issues Precision Genomic Drug Guidance Comments are closed Regulations biomedical, biotechnology, clinical trials, FDA, genomics, life sciences, pharmaceuticals, preclinical, university |
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