EMA receives application for marketing authorisation for Regkirona (regdanvimab) for treating patients with COVID-19

4 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody Regkirona (regdanvimab, also known ...

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EMA evaluating data on booster dose of COVID-19 vaccine Spikevax

27 September 2021 - EMA has started evaluating an application for the use of a booster dose of Spikevax (Moderna’s ...

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EU drugs regulator to decide on Pfizer vaccine booster in early October

23 September 2021 - The EMA aims to decide in early October whether to endorse a third dose of the ...

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Lilly announces procurement agreement with European Commission to supply bamlanivimab and etesevimab together for the treatment of confirmed COVID-19

21 September 2021 - Joint Procurement Agreement enables European countries to purchase bamlanivimab and etesevimab directly from Lilly, in varying ...

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EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty

6 September 2021 - EMA has started evaluating an application for the use of a booster dose of Comirnaty to be ...

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Moderna announces submission of data to European Medicines Agency for its COVID-19 vaccine booster

3 September 2021 - mRNA-1273 at 50 µg dose level induced robust antibody responses of more than 40 times against ...

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Increase in vaccine manufacturing capacity for COVID-19 vaccines from BioNTech/Pfizer and Moderna

24 August 2021 - EMA’s CHMP has adopted recommendations that will increase manufacturing capacity and supply of COVID-19 vaccines in the ...

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EMA starts evaluating use of RoActemra in hospitalised adults with severe COVID-19

16 August 2021 - EMA has started evaluating the anti-inflammatory medicine RoActemra (tocilizumab) to extend its use to include treatment ...

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Novavax and European Commission finalise advance purchase agreement for up to 200 million doses of COVID-19 vaccine

4 August 2021 - Agreement for 100 million doses with option for additional 100 million doses through 2023. ...

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ECDC and EMA update on COVID-19

4  August 2021 - Full vaccination is key to protecting against serious COVID-19, including disease caused by the Delta variant. ...

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Pfizer, Moderna raise prices of COVID-19 coronavirus vaccines for European Union

1 August 2021 - What’s the best way to get more people vaccinated against COVID-19 to try to end the ...

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Increased manufacturing capacity and supply for Spikevax

30 July 2021 - EMA's CHMP has approved a scale-up of the active substance production process at Moderna's COVID-19 vaccine ...

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GSK and Vir Biotechnology announce Joint Procurement Agreement with European Commission for COVID-19 treatment sotrovimab

28 July 2021 - GSK and Vir Biotechnology today announced they have signed a Joint Procurement Agreement with the European ...

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EMA CHMP adopts positive opinion recommending authorisation for the use of the Moderna COVID-19 Vaccine in adolescents (12-17 years of age) in the European Union

23 July 2021 - . 23, 2021-- Moderna today announced that the EMA's CHMP adopted a positive opinion recommending marketing authorisation ...

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COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU

23 July 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine ...

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