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RSS FeedPosted by Michael Wonder on 11 Jun 2021
Moderna files for emergency use authorisation for its COVID-19 vaccine in adolescents in the United States
10 June 2021 - Submission based on Phase 2/3 trial of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 09 Jun 2021
Millions of J&J COVID-19 vaccines are at risk of expiring in June
8 June 2021 - States, hospitals try to reroute such vaccines, while efforts to export them face hurdles. ...
Posted by Michael Wonder on 04 Jun 2021
FDA authorises lower 1,200 mg intravenous and subcutaneous dose of Regen-COV (casirivimab and imevimab) antibody cocktail to treat patients with COVID-19
4 June 2021 - EUA supported by pivotal Phase 3 data showing 1,200 mg dose reduced risk of hospitalisation or death ...
Posted by Michael Wonder on 01 Jun 2021
Moderna announces initiation of rolling submission of biologics license application with US FDA for the Moderna COVID-19 vaccine
1 June 2021 - Moderna today announced that it has initiated the rolling submission process with the U.S. FDA for ...
Posted by Michael Wonder on 31 May 2021
Suspend intellectual property rights for COVID-19 vaccines
28 May 2021 - Waivers are essential for global vaccine equity ...
Posted by Michael Wonder on 27 May 2021
FDA authorises additional monoclonal antibody for treatment of COVID-19
26 May 2021 - Today, the U.S. FDA issued an emergency use authorisation for the investigational monoclonal antibody therapy sotrovimab for ...
Posted by Michael Wonder on 26 May 2021
Influencers say they were urged to criticise Pfizer vaccine
26 May 2021 - A disinformation effort to reduce public confidence in COVID-19 vaccines tried to enrol social media commentators in ...
Posted by Michael Wonder on 20 May 2021
FDA authorises longer time for refrigerator storage of thawed Pfizer-BioNTech COVID-19 vaccine prior to dilution, making vaccine more widely available
19 May 2021 - Based on a review of recent data submitted by Pfizer today, the U.S. FDA is authorising undiluted, ...
Posted by Michael Wonder on 19 May 2021
Top FDA official says fully vaccinated people could need Covid booster shots within a year
18 May 2021 - COVID-19 booster shots could be needed for fully vaccinated people within a year, the FDA’s top ...
Posted by Michael Wonder on 19 May 2021
COVID-19 vaccines: In the rush for regulatory approval, do we need more data?
18 May 2021 - After rollout under emergency authorisation, manufacturers of COVID-19 vaccines now have their sights on regulatory approval. ...
Posted by Michael Wonder on 18 May 2021
Biden pledges to export millions of FDA authorised vaccines
18 May 2021 - President says U.S. will have enough for entire population. ...
Posted by Michael Wonder on 17 May 2021
Statement on leronlimab
17 May 2021 - FDA recognizes the substantial public interest in medicines that are being studied for the prevention or treatment ...
Posted by Michael Wonder on 14 May 2021
Vaccine patent waivers deserve a warning label
13 May 2021 - The move to suspend patents on COVID-19 vaccines opens up a major risk to the way the ...
Posted by Michael Wonder on 11 May 2021
FDA grants fast track designation to CERC-002 for treatment of hospitalised patients with COVID-19
11 May 2021 - Cerecor today announced that the U.S. FDA has granted fast track designation to CERC-002 for treatment of ...
Posted by Michael Wonder on 10 May 2021
FDA authorizes Pfizer-BioNTech COVID-19 vaccine for emergency use in adolescents in another important action in fight against pandemic
10 May 2021 - Today, the U.S. FDA expanded the emergency use authorisation for the Pfizer-BioNTech COVID-19 vaccine for the prevention ...