Feb 24, 2021 | News, Regulatory
Sinopharm, a unit of the China National Pharmaceutical Group, and CanSinoBiologics Inc both have applied in China for the public use of their COVID-19 vaccines. Currently, China has two approved vaccines that were developed within the country, and has yet to approve... 
Feb 16, 2021 | News, Regulatory
The World Health Organization (WHO) announced yesterday (2/15) its approval of emergency use authorization (EUA) of the AstraZeneca-Oxford COVID-19 vaccine. The vaccine is currently approved in the UK and EU, and the WHO’s approval opens more doors for other nations... 
Feb 12, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) granted BD Emergency Use Authorization (EUA) for a new molecular diagnostic test for COVID-19 and the Influenza A+B virus that provides results within 2-3 hours. The test has already been CE marked for the IVD Directive.... 
Feb 11, 2021 | News, Regulatory
The U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) the Eli Lilly’s etesevimab in combination with another AbCellera and Eli Lilly’s monoclonal antibody bamlanivimab for treating mild to moderate COVID-19 in patients 12 years or... 
Feb 10, 2021 | News, Regulatory
Pfizer announced that it was withdrawing its application for emergency use authorization (EUA) in India for its COVID-19 vaccine. The pharmaceutical company failed to meet India’s regulatory requirements for a local immunogenicity study to ensure the safety of the...
