Tag: FDA
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FDA Okays Lower Dose, Injected Covid-19 Antibodies
The Food and Drug Administration updated its emergency authorization for a dual-antibody Covid-19 therapy to allow for a lower and injectable dose.
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Infographic – U.S. Kids Vaccine Status Matches Parents
Findings from the YouGov poll show the likelihood of children in the U.S. getting a Covid-19 vaccine depends largely on their parents’ vaccination status or plans.
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Antibody Clears Covid-19 Variants, Enters Trial
A synthetic antibody is shown in lab tests to neutralize variants of the SARS-CoV-2 virus, and will be added to an ongoing clinical trial of Covid-19 therapies.
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Lilly Asks FDA to Revoke Covid-19 Therapy Clearance
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.
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Trial to Test Direct Crispr Blood Stem Cell Edits
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.
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FDA Clears Covid-19 Nasal Spray/Drops Vaccine Trial
A company developing vaccines delivered through the nose received FDA clearance to begin a clinical trial of its vaccine protecting against Covid-19 infections.
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FDA Authorizes Non-Prescription Covid-19 Test
Food and Drug Administration granted an emergency authorization for a molecular test for SARS-CoV-2 viruses done at home without a prescription.
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NIH Assessing Home Covid-19 Diagnostic with App
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.
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ALS Trial Results Deemed Insufficient for FDA Approval
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.
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FDA Issues Covid-19 Variant Regulatory Guidance
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.