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The FDA Tracks COVID-19 Mutations Impact on Diagnostic Performance

The FDA Tracks COVID-19 Mutations Impact on Diagnostic Performance

Jan 8, 2021 | News, Regulatory

On Wednesday (1/6) the U.S. Food and Drug Administration (FDA) announced that it is tracking the COVID-19 testing diagnostics with SARS-CoV-2 test developers to determine the efficacy of the already-approved tests on their ability to detect new COVID-19 variants. The...
AstraZeneca Unlikely to Receive EUA Approval Until April

AstraZeneca Unlikely to Receive EUA Approval Until April

Dec 31, 2020 | News, Regulatory

According to Operation Warp Speed Chief, Moncef Slaoui, the AstraZeneca and Oxford University vaccine may not receive the U.S. Food and Drug Administration’s Emergency Use Approval (EUA) until April, despite the UK’s approval yesterday (12/30). Questions...
NeuroRx and Relief Therapeutics Approved to Commence Phase 2b/3 Trial for ZYESAMI

NeuroRx and Relief Therapeutics Approved to Commence Phase 2b/3 Trial for ZYESAMI

Dec 30, 2020 | News, Regulatory

NeuroRx and Relief Therapeutics have completed enrollment for their phase 2b/3 clinical trial for their treatment of respiratory failure in patients with severe cases of COVID-19. The trial, who’s top-line data is expected in one month, has...
Moderna COVID-19 Vaccine Receives FDA Emergency Use Authorization

Moderna COVID-19 Vaccine Receives FDA Emergency Use Authorization

Dec 21, 2020 | News, Regulatory

On Friday (12/18) The U.S Food and Drug Administration granted Moderna Emergency Use Authorization for their COVID-19 vaccine in adults over 18 years old. In addition to Pfizer’s vaccine, the U.S government agreed to purchase 200 million doses from Moderna which will...
Emergency Use Authorization Given to Ellume’s At-Home COVID-19 Test

Emergency Use Authorization Given to Ellume’s At-Home COVID-19 Test

Dec 16, 2020 | News, Regulatory

On December 15, 2020, the U.S. Food and Drug Administration (FDA) approved the first over the counter fully at-home COVID-19 Test. The test delivers results in approximately 20 minutes and diagnoses individuals as young as two years old and is expected to be delivered...
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