26 July 2021 - Opinion based on results from Ultomiris Phase 3 trial that showed an established efficacy and safety ...
23 July 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine ...
21 July 2021 - Skysona is the first and only gene therapy approved in the European Union to treat early CALD. ...
22 June 2021 - First medicine approved in the EU to treat this rare and debilitating genetic condition. ...
18 June 2021 - The European Commission has approved Aubagio (teriflunomide) for the treatment of paediatric patients 10 to 17 years ...
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
28 May 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
3 May 2021 - EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to ...
26 April 2021 - Recommendation based on the SPRINT Phase 2 trial, which showed selumetinib reduced tumour volume in children. ...
26 March 2021 - Novo Nordisk today announced that the CHMP under the EMA has recommended that the use of Saxenda ...
26 February 2021 - If approved, somatrogon will serve as a once-weekly treatment option. ...
13 January 2021 - Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg ...
30 November 2020 - Pivotal trial showed more than four times as many children achieved itch reduction and more than three ...
27 November 2020 - The combination therapy is a new treatment option for CF patients who are homozygous for F508del. ...
16 November 2020 - Eisai announced that it has been received approval from the European Commission for the use of its ...