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RSS FeedPosted by Michael Wonder on 07 Oct 2020
Eli Lilly asks FDA to authorise COVID-19 antibody drug
7 October 2020 - Company says it could supply one million doses of the treatment this year, if regulator authorises emergency ...
Posted by Michael Wonder on 07 Oct 2020
FDA issues guidance on Emergency Use Authorisation for COVID-19 vaccines
6 October 2020 - Today, the U.S. FDA issued guidance with recommendations for vaccine sponsors regarding the scientific data and ...
Posted by Michael Wonder on 06 Oct 2020
FDA discloses vaccine guidelines blocked by White House
7 October 2020 - The FDA has laid out its safety standards for developers of COVID-19 vaccines after the White House ...
Posted by Michael Wonder on 05 Oct 2020
Moderna CEO says COVID-19 vaccine will be ready for FDA submission in late November
5 October 2020 - Company will seek emergency use authorisation for experimental vaccine. ...
Posted by Michael Wonder on 02 Oct 2020
Biotech industry pushes Trump Administration to release new vaccine guidelines
2 October 2020 - The BIO trade group, whose members include most of the vaccine makers, asked the health secretary to ...
Posted by Michael Wonder on 02 Oct 2020
Development of COVID-19 vaccine won’t be affected by politics, Pfizer CEO says
1 October 2020 - Albert Bourla sent an all-hands letter saying company won’t bow to political pressure. ...
Posted by Michael Wonder on 02 Oct 2020
HHS says Gilead, distributor can directly sell COVID-19 drug in U.S.
1 October 2020 - The U.S. Department of Health and Human Services said on Thursday that U.S. hospitals can now ...
Posted by Michael Wonder on 01 Oct 2020
US to widen inquiry into AstraZeneca COVID vaccine destined for Australia
1 October 2020 - The US Food and Drug Administration has broadened its investigation of a serious illness in AstraZeneca's ...
Posted by Michael Wonder on 29 Sep 2020
FDA chief stands by vaccine approval criteria despite Trump pressure
29 September 2020 - The FDA, under commissioner Stephen Hahn, is in the middle of one of the most highly charged ...
Posted by Michael Wonder on 29 Sep 2020
Pfizer CEO on the pressures of creating a COVID-19 vaccine: ‘what is at stake is beyond imagination'
30 September 2020 - Albert Bourla, 58, is chairman and chief executive of Pfizer, a multinational pharmaceutical company. Bourla is a ...
Posted by Michael Wonder on 24 Sep 2020
AstraZeneca boss says transparency key for vaccine
24 September 2020 - The chief executive of AstraZeneca has said the public must trust that multiple regulators will review ...
Posted by Michael Wonder on 24 Sep 2020
FDA authorises first point of care antibody test for COVID-19
23 September 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first serology (antibody) point of care ...
Posted by Michael Wonder on 24 Sep 2020
Trump claims White House can overrule FDA's attempt to toughen guidelines for coronavirus vaccine
24 September 2020 - President Donald Trump claimed Wednesday that the White House could override the US FDA if the ...
Posted by Michael Wonder on 23 Sep 2020
FDA poised to announce tougher standards for a COVID-19 vaccine that make it unlikely one will be cleared by Election Day
23 September 2020 - The guidance is part of an effort to boost transparency and public trust as polls show many ...
Posted by Michael Wonder on 21 Sep 2020
You can trust the FDA’s vaccine process
20 September 2020 - The agency can roll out a Covid shot safely, quickly and without bowing to political pressure. ...