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. ...

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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 ...

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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. ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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 ...

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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. ...

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Coronavirus vaccine: Donald Trump contradicts CDC director Robert Redfield

17 September 2020 - Donald Trump has issued an extraordinary public rebuke to his own government’s top health official, labelling him ...

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Up is down — pharmaceutical industry caution versus federal acceleration of COVID-19 vaccine approval

15 September 2020 - Nine pharmaceutical company leaders took the unprecedented step on 8 September 2020, of stating that they would ...

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FDA publishes comparative performance data for COVID-19 molecular diagnostic tests

15 September 2020 - Today, the U.S. FDA published comparative performance data for some authorised COVID-19 molecular diagnostic tests.  ...

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