24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license. ...
23 November 2023 - More than 1,200 children are newly eligible for a medicine that could treat the underlying cause ...
2 November 2023 - Gedeon Richter together with Sumitomo today announce that the European Commission has granted approval of a type ...
13 October 2023 - Final decision from the European Commission expected by the end of 2023. ...
15 September 2023 - If approved, more than 1,200 children would be newly eligible for a medicine that could treat ...
5 July 2023 - Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible ...
28 June 2023 - Seeking inclusion of CV risk reduction indications in Europe. ...
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...
23 June 2023 - Amylyx will seek re-examination of its conditional marketing authorisation application. ...
23 February 2023 - The authorisation is an important step to meet ViiV Healthcare’s commitment to bring paediatric formulations to children ...
27 January 2023 - Pfizer today announced that the CHMP of the EMA has recommended converting the conditional marketing authorisation ...
29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...
20 September 2022 - Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase 3 treatment trial. ...
16 September 2022 - Recommendation based on TACKLE Phase 3 treatment data showing reduced risk of severe COVID-19 or death. ...
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...