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RSS FeedPosted by Michael Wonder on 08 Nov 2021
COVID-19: EMA and Heads of Medicines Agencies update on molnupiravir
8 November 2021 - EMA starts review to support possible national decisions on early use. ...
Posted by Michael Wonder on 02 Nov 2021
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly
2 November 2021 - EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of ...
Posted by Michael Wonder on 02 Nov 2021
Novavax files for COVID-19 vaccine authorisation with Health Canada and completes submission for rolling review to European Medicines Agency
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete ...
Posted by Michael Wonder on 25 Oct 2021
Spikevax: EMA recommendation on booster
25 October 2021 - The EMA’s CHMP has concluded that a booster dose of the COVID-19 vaccine Spikevax (from Moderna) ...
Posted by Michael Wonder on 25 Oct 2021
Merck and Ridgeback announce initiation of a rolling review by the European Medicines Agency for molnupiravir, an investigational oral anti-viral medicine, for the treatment of COVID-19 in adults
25 October 2021 - If granted marketing authorisation by the European Commission, molnupiravir could be the first oral anti-viral medicine for ...
Posted by Michael Wonder on 25 Oct 2021
COVID-19: EMA starts rolling review of molnupiravir
25 October 2021 - EMA’s CHMP has started a rolling review of the oral antiviral medicine molnupiravir (MK 4482; Lagevrio), ...
Posted by Michael Wonder on 24 Oct 2021
EU decision on Russia's Sputnik V shot 'impossible' this year
21 October 2021 - The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until ...
Posted by Michael Wonder on 18 Oct 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
18 October 2021 - EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to ...
Posted by Michael Wonder on 14 Oct 2021
EMA starts rolling review of Evusheld (tixagevimab and cilgavimab)
14 October 2021 - EMA’s CHMP has started a rolling review of Evusheld (also known as AZD7442), a combination of ...
Posted by Michael Wonder on 13 Oct 2021
EU may consider deal on Merck's COVID pill after approval procedure begins
12 October 2021 - The European Union may consider signing a supply deal with U.S. drugmaker Merck for its experimental ...
Posted by Michael Wonder on 12 Oct 2021
EMA ends rolling review of CVnCoV COVID-19 vaccine following withdrawal by CureVac
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
Posted by Michael Wonder on 11 Oct 2021
EMA receives application for marketing authorisation for Ronapreve (casirivimab with imdevimab) for treatment and prevention of COVID-19
11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...
Posted by Michael Wonder on 06 Oct 2021
Moderna announces European Medicines Agency authorises third dose of COVID-19 vaccine for immunocompromised individuals aged 12 years and older
5 October 2021 - Moderna today announced that the EMA has authorised a third dose of the Moderna COVID-19 vaccine (Spikevax) ...
Posted by Michael Wonder on 06 Oct 2021
EMA to consider rolling review for Merck's molnupiravir in coming days
5 October 2021 - The EMA will consider in the coming days whether to launch a rolling review of Merck's ...
Posted by Michael Wonder on 05 Oct 2021
Comirnaty and Spikevax: EMA recommendations on extra doses and boosters
4 October 2021 - EMA’s CHMP has concluded that an extra dose of the COVID-19 vaccines Comirnaty (BioNTech/Pfizer) and Spikevax ...