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Home » Topics » COVID-19

COVID-19
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Midge Medical Receives CE-IVD Mark for Minoo Test System

September 19, 2022
The company plans to introduce this system to the German market in the fourth quarter of this year. Read More

DiaSorin Gets 510(k) Clearance for Simplexa COVID-19 Test

September 16, 2022
The development of the product was funded by HHS’ Administration for Strategic Preparedness and Response as well as the Biomedical Advanced Research and Development Authority. Read More

EMA’s CHMP Recommends Pfizer and BioNTech’s Adapted Comirnaty Vaccine

September 14, 2022
Clinical studies with Comirnaty Original/Omicron BA.4-5 are ongoing. Read More

IMHE Modeling Shows 307 Percent Increase in Long COVID Cases From 2020 to 2021

September 14, 2022
Nearly 145 million people worldwide experienced symptoms during that timeframe. Read More

MagBio Receives 510(k) Clearance and CE Mark for MagXtract Collection Tube

September 14, 2022
The product is the first guanidine-free molecular transport medium, FDA-cleared device available in the U.S. Read More

Updated Pfizer-BioNTech and Moderna COVID-19 Boosters Expected Within Days

September 6, 2022
With these new EUAs in place, FDA has decided to no longer authorize the monovalent mRNA COVID-19 booster doses. Read More

IncellDx Gains CE-IVD Mark for ‘Long COVID’ Diagnostic

September 2, 2022
The blood test showed more than 90 percent accuracy in a validation study. Read More

Califf is Bullish on Newly Authorized Bivalent COVID-19 Boosters Ahead of Data

September 1, 2022
In the midst of a pandemic, if you wait for all the data to come in, “you’ve missed the boat,” said FDA Commissioner Robert Califf yesterday regarding the agency authorizing both Pfizer/BioNTech’s and Moderna’s bivalent COVID-19 boosters before any clinical trials on them are complete. Read More

UK Expands Authorization of Novavax’s COVID-19 Vaccine to Include Adolescents 12 to 17

August 30, 2022
The vaccine demonstrated 80 percent efficacy against the Delta variant of the SARS-CoV-2 virus. Read More

FDA Approves Single-Dose Vial Presentations of Comirnaty COVID-19 Vaccine

August 30, 2022
Unlike some multiple-dose vials, the single-dose vaccine must not be diluted. Read More

Moderna Completes EUA Application for Omicron-Targeting Bivalent COVID-19 Booster

August 25, 2022
The updated booster shot may offer broader and more durable protection against COVID-19, the company said. Read More

Pfizer and BioNTech Submit EUA Application for Omicron-Adapted Bivalent COVID-19 Vaccine

August 24, 2022
Pending authorization, the Omicron BA.4/BA.5-adapted bivalent vaccine will be available to ship immediately, the companies said. Read More
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