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Home » Topics » COVID-19

COVID-19
COVID-19 RSS Feed RSS

FDA Expands EUA for Twist Bioscience SARS-CoV-2 NGS Assay

August 5, 2022
Emergency use of the test is limited to laboratories that meet requirements to perform high complexity tests. Read More

FDA Grants EUA to Helix Diagnostics SARS nCOV-2019 Multiplexed Assay Test

August 5, 2022
Under the EUA, the agency limits analysis of the test samples to Helix Diagnostics’ laboratory in Waterford, Mich. Read More

European Commission Orders HIPRA’s COVID-19 Vaccine

August 3, 2022
The commission is expected to grant the vaccine a conditional authorization sometime this year. Read More

Axcella’s Investigational Drug Shows Promise in Long COVID Clinical Trial

August 3, 2022
People who took AXA1125 had statistically significant improvements in their level of mental and physical fatigue. Read More

FDA Provides Update on North American Diagnostics’ Recall of SARS-CoV-2 Test Kits

August 3, 2022
So far, no complaints or reports of injuries or deaths have been linked to the test kits, the FDA said. Read More

U.S. Orders 66 Million Doses of Moderna’s Bivalent COVID-19 Booster Vaccine

August 1, 2022
Moderna’s bivalent booster has yet to be authorized by the FDA for emergency use. Read More

BioGX’s Pixl16 COVID-19 Test Gets CE-IVD Mark

August 1, 2022
The test can deliver results on up to 16 samples in less than an hour, the company said. Read More

FDA Grants EUA to Predicine’s Pooled COVID-19 Test

July 26, 2022
Analysis of the samples is limited to Predicine’s Hayward, Calif. laboratory. Read More

DiaCarta’s SARS-CoV-2 and Flu A/B Test Gets CE-IVD Mark

July 25, 2022
The company plans on submitting the test to the FDA for Emergency Use Authorization and 510(k) clearance. Read More

Japan’s Health Ministry Delays Emergency Approval of Shionogi’s COVID-19 Treatment

July 21, 2022
If approved, Xocova would be the third COVID-19 oral treatment approved in Japan. Read More

CDC Endorses Novavax COVID-19 Vaccine

July 21, 2022
“If you have been waiting for a COVID-19 vaccine built on a different technology than those previously available, now is the time to join the millions of Americans who have been vaccinated,” said CDC Director Rochelle Walensky. Read More

FDA Grants EUA to Genabio’s COVID-19 Test Kit

July 20, 2022
The test must be administered twice, with 24-48 hours between each test. Read More
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