CSL warns AstraZeneca booster shots not available until end of year

2 March 2021 - Australia’s COVID-19 vaccine maker CSL says it is open to making booster shots for AstraZeneca for ...

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Drug industry pushes FDA to solve growing inspection backlog

2 March 2021 - Inspections are a vital tool to ensure the safety of new drugs as well as medicines already ...

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Three steps can help companies speed FDA approval of new drugs

24 February 2021 - Drug developers see FDA approval as a difficult uphill climb, requiring large investments of resources and ...

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Where is AstraZeneca’s vaccine? Health Canada says not yet ready to greenlight

18 February 2021 - Health Canada is not yet ready to make a decision about approving the COVID-19 vaccine from ...

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COVID-19 vaccine approval process: does it take too long?

15 February 2021 - Here are answers to some questions about the FDA review panels. ...

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EMA expected to approve Johnson & Johnson vaccine by March

10 February 2021 - The European Medicines Agency is expected to give its approval to the COVID-19 vaccine developed by ...

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Due to aducanumab’s new PDUFA date, ICER extends timeline for Alzheimer’s disease assessment

10 February 2021 - The ICER announced today it has extended its timeline for assessing the comparative clinical effectiveness and ...

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Biogen and Eisai announce FDA's 3 month extension of review period for the biologics license application for aducanumab

29 January 2021 - The new Prescription Drug User Fee Act action date set by the FDA is 7 June ...

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Medicines NZ hopes country can roll out COVID-19 vaccines early

19 January 2021 - Medical professionals are hopeful New Zealand is in a position to roll out COVID-19 vaccines early. ...

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FDA sped progress for most of 2020's novel drugs

14 January 2021 - Most novel drugs approved by the US FDA in 2020 made their way through the approvals process ...

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COVID-19: NZ vaccine timeline remains the same in light of new variant strains

13 January 2021 - New Zealand does not have any plans to fast-track its Covid-19 vaccine roll-out in light of ...

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Johnson & Johnson could apply for EMA approval in February

14 January 2021 - US pharmaceutical company Johnson & Johnson may submit an official application for approval of its COVID-19 ...

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SMC to support innovative new medicines pathway

29 December 2020 - Experts from the Scottish Medicines Consortium are to support a new licensing and access pathway which ...

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TGA still waiting for 'further data' on AstraZeneca vaccine

4 January 2020 - Concerns over new coronavirus cases in Sydney and Melbourne look unlikely to prompt an accelerated approval ...

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FDA could authorise Pfizer’s COVID-19 vaccine this week as U.S. deaths surge

7 December 2020 - An FDA advisory group is scheduled to convene on Thursday to review Pfizer’s vaccine. ...

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