11 November 2021 - EMA’s CHMP has recommended authorising Ronapreve (casirivimab/imdevimab) and Regkirona (regdanvimab) for COVID-19. ...
10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...
9 November 2021 - Submission based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11. ...
8 November 2021 - EMA starts review to support possible national decisions on early use. ...
2 November 2021 - EMA has ended the rolling review of bamlanivimab and etesevimab, two antibodies for the treatment of ...
1 November 2021 - Submission of all modules required for regulatory review, including CMC and clinical data, are now complete ...
25 October 2021 - The EMA’s CHMP has concluded that a booster dose of the COVID-19 vaccine Spikevax (from Moderna) ...
25 October 2021 - If granted marketing authorisation by the European Commission, molnupiravir could be the first oral anti-viral medicine for ...
25 October 2021 - EMA’s CHMP has started a rolling review of the oral antiviral medicine molnupiravir (MK 4482; Lagevrio), ...
21 October 2021 - The EU drug regulator is unlikely to decide whether to approve Russia's Sputnik V coronavirus vaccine until ...
18 October 2021 - EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to ...
14 October 2021 - EMA’s CHMP has started a rolling review of Evusheld (also known as AZD7442), a combination of ...
12 October 2021 - The European Union may consider signing a supply deal with U.S. drugmaker Merck for its experimental ...
13 October 2021 - The EMA has ended the rolling review of CVnCoV, CureVac AG’s COVID-19 vaccine, after the company ...
11 October 2021 - EMA has started evaluating an application for marketing authorisation for the monoclonal antibody combination Ronapreve (casirivimab ...