Remdesivir (Veklury) approval for the treatment of COVID-19—the evidence for safety and efficacy

26 November 2020 - Under FDA law, approval of a new drug requires substantial evidence of effectiveness and a demonstration of ...

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Third major COVID-19 vaccine shown to be effective and cheaper

24 November 2020 - Drugmaker AstraZeneca said late-stage trials showed its COVID-19 vaccine is highly effective, buoying the prospects of a ...

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Pfizer vaccine distribution could kick off within weeks pending FDA approval, Azar says

24 November 2020 - A FDA panel will meet on 10 December to consider Pfizer’s emergency use authorisation application for its ...

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Doctors say CDC should warn people the side effects from COVID vaccine shots won’t be ‘a walk in the park’

23 November 2020 - The CDC must be transparent about the side effects people may experience after getting their first shot ...

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Success for a third—and perhaps most important—COVID-19 vaccine

23 November 2020 - The AstraZeneca-Oxford jab is likely to be widely used around the world. ...

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COVID-19 shots could reach first Americans by mid-December, top health official says

23 November 2020 - U.S. health care workers and others recommended for the nation’s first COVID-19 inoculations could start getting shots ...

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Politics, science and the remarkable race for a coronavirus vaccine

21 November 2020 - The furious race to develop a coronavirus vaccine played out against a presidential election, between a pharmaceutical ...

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FDA authorises drug combination for treatment of COVID-19

19 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the drug baricitinib, in combination with ...

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Pfizer will seek regulatory review ‘within days’ for its vaccine

18 November 2020 - The coronavirus vaccine being developed by Pfizer and German biotechnology firm BioNTech is 95% effective at ...

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The vaccines will probably work. Making them fast will be the hard part.

18 November 2020 - Front-runners in the coronavirus vaccine race won’t make nearly as many doses this year as were predicted, ...

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FDA authorises first COVID-19 test for self-testing at home

17 November 2020 - Today, the U.S. FDA issued an emergency use authorisation for the first COVID-19 diagnostic test for self-testing ...

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Pfizer has enough safety data about its coronavirus vaccine and is preparing to submit for FDA authorisation, CEO says

17 November 2020 - Pfizer has accumulated enough safety data on its COVID-19 vaccine and is preparing to file for ...

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Does remdesivir actually work against COVID-19?

17 November 2020 - The evidence shows only that the drug might be effective. That once wasn’t enough for FDA approval. ...

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FDA’s ongoing commitment to transparency for COVID-19 EUAs

17 November 2020 - Emergency use authorisations, or EUAs, are an important tool in our country’s fight against COVID-19 and other ...

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HHS Secretary Azar says the FDA will move ‘as quickly as possible’ to clear Moderna and Pfizer’s COVID-19 vaccines

16 November 2020 - There should be enough vaccine doses made by Pfizer and Moderna to inoculate roughly 20 million before ...

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