Last updated 18th December 2020

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EMA’s human medicines committee (CHMP) has recommended updating the product information for Comirnaty to clarify that each vial contains 6 doses of...
New England Journal of Medicine, Volume 384, Issue 3, January 2021.
New England Journal of Medicine, Volume 384, Issue 3, Page 289-291, January 2021.
New England Journal of Medicine, Ahead of Print.
New England Journal of Medicine, Ahead of Print.

Help meet the increased demand for safe and effective hand sanitizers during the COVID-19 public health emergency

COVID-19
EMA has endorsed a joint statement published today by the International Coalition of Medicines Regulatory Authorities (ICMRA) to inform and help...

This guidance is being issued to address the Coronavirus Disease 2019 (COVID-19) public health emergency.
The ongoing investigation of the cyberattack on EMA revealed that some of the unlawfully accessed documents related to COVID-19 medicines and vaccines...
First monthly summary safety report for COVID-19 vaccine ComirnatyStarting this month, EMA’s safety committee (PRAC) will evaluate summary safety reports...

Pandemic Recovery and Preparedness Plan (PREPP) initiative strengthens on-going COVID-19 pandemic response and our resiliency for future public health emergencies.

Due to the current public health emergency, FDA is issuing this guidance to assist sponsors in the development of monoclonal antibodies (mAbs) and other therapeutic proteins for use as COVID-19...
New England Journal of Medicine, Volume 384, Issue 2, January 2021.
New England Journal of Medicine, Ahead of Print.