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RSS FeedPosted by Michael Wonder on 06 Apr 2022
U.S. FDA aims to decide on strain selection for COVID boosters by June
6 April 2022 - The U.S. FDA said it is aiming to come up with a decision on coronavirus strain ...
Posted by Michael Wonder on 05 Apr 2022
FDA updates sotrovimab emergency use authorisation
5 April 2022 - Sotrovimab is no longer authorised to treat COVID-19 in any U.S. region due to increases in ...
Posted by Michael Wonder on 04 Apr 2022
FDA shuts out its own experts in authorising another vaccine booster
3 April 2022 - Decisions like this only reinforce the perception that Covid policy is driven by groupthink and politics. ...
Posted by Michael Wonder on 04 Apr 2022
U.S. FDA grants priority review to Roche’s Actemra/RoActemra for the treatment of COVID-19 in hospitalised adults
4 April 2022 - If approved, Actemra/RoActemra would be the first U.S. FDA approved immunomodulator for the treatment of COVID-19 in ...
Posted by Michael Wonder on 30 Mar 2022
Enanta Pharmaceuticals receives FDA fast track designation for EDP-235, its oral 3CL protease inhibitor specifically designed for the treatment and prevention of COVID-19
29 March 2022 - Enanta Pharmaceuticals today announced that the U.S. FDA has granted fast track designation for EDP-235, its ...
Posted by Michael Wonder on 29 Mar 2022
FDA authorises second booster dose of two COVID-19 vaccines for older and immunocompromised individuals
29 March 2022 - Today, the U.S. FDA authorised a second booster dose of either the Pfizer-BioNTech or the Moderna COVID-19 ...
Posted by Michael Wonder on 23 Mar 2022
Moderna has initiated a submission to the FDA for emergency use authorization of mRNA-1273 in children 6 to under 12 years of age
23 March 2022 - Moderna today announced positive interim data from the Phase 2/3 KidCOVE study of the Moderna COVID-19 ...
Posted by Michael Wonder on 18 Mar 2022
Moderna submits amendment to the emergency use authorisation for an additional booster dose of its COVID-19 vaccine in the U.S.
17 March 2022 - Moderna today announced that it has submitted a request to the U.S. FDA for an amendment ...
Posted by Michael Wonder on 16 Mar 2022
Consequences of lack of funding for efforts to combat COVID-19 if Congress does not act
15 March 2022 - The U.S. has made tremendous progress in our fight against COVID-19. ...
Posted by Michael Wonder on 16 Mar 2022
Pfizer and BioNTech submit for U.S. emergency use authorisation of an additional booster dose of their COVID-19 vaccine for older adults
15 March 2022 - Submission based on real-world safety and efficacy data from Israel. ...
Posted by Michael Wonder on 10 Mar 2022
When desperate patients go to court for unproven treatments - the battle for hospital independence
9 March 2022 - During the COVID-19 pandemic, patients have asked courts to compel hospitals to administer unproven therapies, including ivermectin. ...
Posted by Michael Wonder on 07 Mar 2022
Novavax’s Covid-19 vaccine moves closer to FDA authorisation decision
6 March 2022 - Company says it has resolved manufacturing problems that led to earlier delays; FDA is reviewing shot’s authorisation ...
Posted by Michael Wonder on 19 Feb 2022
FDA eyes second COVID-19 booster shot
19 February 2022 - The agency has begun reviewing data that could lead to clearing a second booster dose of ...
Posted by Michael Wonder on 12 Feb 2022
Pfizer and BioNTech provide update on rolling submission for emergency use authorisation of their COVID-19 vaccine in children 6 months through 4 years of age
11 February 2022 - Pfizer and BioNTech today announced plans to extend their rolling submission to the U.S. FDA seeking ...
Posted by Michael Wonder on 11 Feb 2022
Lilly's bebtelovimab receives emergency use authorisation for the treatment of mild to moderate COVID-19
11 February 2022 - Bebtelovimab neutralises Omicron as demonstrated by pseudovirus and authentic virus data ...