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November 23, 2020
Following an EUA application from Pfizer and NioNTech, FDA outlines the process for committee and agency review.
November 19, 2020
Researchers concluded that the nasal spray should catch and coat the virus inside the nose, preventing it from spreading throughout the body, and it is then removed by nose-blowing or swallowing.
A second global Phase III clinical trial investigating the safety and efficacy of a two-dose regimen of JNJ-78436735 has been initiated by Johnson & Johnson.
Interim results of AZD1222 trial have demonstrated lower reactogenicity in older adults, and strong immune responses across all adult age groups.
Almac Sciences has been granted an award by the COVID-19 Therapeutics Accelerator for the development of an efficient and scalable production process for remdesivir.
Moderna has reported that EMA's CHMP has started a rolling review of mRNA-1273—Moderna’s COVID-19 vaccine candidate.
November 18, 2020
The agency’s safety monitoring plan outlines how information that emerges after the authorization of COVID-19 vaccines will be collected and reviewed.
EDQM announced three new Official Control Authority Batch Release guidelines that describe the tests to be performed by Official Medicines Control Laboratories in the European Union OCABR Network.
Stephen Hahn promises disclosure of supporting scientific data used to issue EUAs.
The agency recommended treatments for a variety of cancers as well as treatments for glaucoma and influenza.