Drug maker Eli Lilly and Co. asked the Food and Drug Administration to revoke its authorization for bamlanivimab alone to treat for Covid-19 infections. . . . → Read More: Lilly Asks FDA to Revoke Covid-19 Therapy Clearance
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 One comment - (Comments are closed)  Regulations  biomedical, biotechnology, Covid-19, FDA, life sciences, pharmaceuticals 
A clinical trial is underway testing for allergic reactions to Covid-19 vaccines using messenger RNA for invoking an immune response. . . . → Read More: NIH Trial Testing mRNA Vaccine Allergic Effects One comment - (Comments are closed) New products, Regulations biomedical, biotechnology, clinical trials, Covid-19, Europe, genomics, life sciences, NIH, pharmaceuticals 
An analysis of customer transactions shows discounts from suppliers are used for only a small fraction of prescription drugs on the market. . . . → Read More: Coupons, Vouchers Used for Few Prescription Drugs 
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 
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 One comment - (Comments are closed) Regulations biomedical, Covid-19, engineering, Europe, genomics, life sciences, medical device 
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 |
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