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Trial to Test Direct Crispr Blood Stem Cell Edits

Sickle cells illustration

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

FDA Clears Covid-19 Nasal Spray/Drops Vaccine Trial

Nasal spray

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

FDA Authorizes Non-Prescription Covid-19 Test

Cue 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. . . . → Read More: FDA Authorizes Non-Prescription Covid-19 Test

NIH Assessing Home Covid-19 Diagnostic with App

QuickVue test package

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

ALS Trial Results Deemed Insufficient for FDA Approval

Neurons illustration

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

FDA Issues Covid-19 Variant Regulatory Guidance

Covid-19 testing

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

20 Precision Meds Approved by FDA in 2020

Syringe, pills, capsules

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

FDA Clears Covid-19 Dual-Antibody Therapy

SARS-Cov-2 viruses

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

Monthly HIV Drug Combo Approved by FDA

HIV released from cell

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

US Govt to Buy 1.25M Regeneron Covid-19 Therapies

SARS-Cov-2 virus

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