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RSS FeedPosted by Michael Wonder on 25 Nov 2023
Vertex announces EMA validation for marketing authorisation application extension for Kaftrio in combination with ivacaftor to include people with cystic fibrosis and responsive rare mutations
24 November 2023 - Application to add ~200 non-F508del CFTR mutations to the Kaftrio license. ...
Posted by Michael Wonder on 23 Nov 2023
European Commission approves Kaftrio in combination with ivacaftor for the treatment of children with cystic fibrosis ages 2 through 5
23 November 2023 - More than 1,200 children are newly eligible for a medicine that could treat the underlying cause ...
Posted by Michael Wonder on 03 Nov 2023
EC approves Ryeqo for the symptomatic treatment of endometriosis
2 November 2023 - Gedeon Richter together with Sumitomo today announce that the European Commission has granted approval of a type ...
Posted by Michael Wonder on 14 Oct 2023
Amylyx Pharmaceuticals receives negative CHMP opinion on its marketing authorisation application for AMX0035 for the treatment of ALS in the European Union following re-examination process
13 October 2023 - Final decision from the European Commission expected by the end of 2023. ...
Posted by Michael Wonder on 16 Sep 2023
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor for children with cystic fibrosis ages 2 through 5
15 September 2023 - If approved, more than 1,200 children would be newly eligible for a medicine that could treat ...
Posted by Michael Wonder on 05 Jul 2023
European Commission approves Orkambi (lumacaftor/ivacaftor) for the treatment of children with cystic fibrosis ages 1 to 2 years old
5 July 2023 - Nearly 300 children with cystic fibrosis and two copies of the F508del mutation are now eligible ...
Posted by Michael Wonder on 29 Jun 2023
Esperion announces submission of application for expanded indication with the EMA for Nilemdo (bempedoic acid) tablet and Nustendi (bempedoic acid and ezetimibe) tablet
28 June 2023 - Seeking inclusion of CV risk reduction indications in Europe. ...
Posted by Michael Wonder on 27 Jun 2023
Janssen submits marketing authorisation application to the EMA seeking approval of single tablet combination therapy of macitentan and tadalafil for treatment of patients with pulmonary arterial hypertension
26 June 2023 - This is the first and only single tablet combination therapy to be submitted for review in Europe ...
Posted by Michael Wonder on 24 Jun 2023
Amylyx Pharmaceuticals receives CHMP negative opinion on its conditional marketing authorisation application for AMX0035 for the treatment of ALS in the European Union
23 June 2023 - Amylyx will seek re-examination of its conditional marketing authorisation application. ...
Posted by Michael Wonder on 24 Feb 2023
ViiV Healthcare receives EU marketing authorisation for Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once daily treatment for Children living with HIV in Europe
23 February 2023 - The authorisation is an important step to meet ViiV Healthcare’s commitment to bring paediatric formulations to children ...
Posted by Michael Wonder on 29 Jan 2023
Pfizer receives positive CHMP opinion for conversion of Paxlovid conditional marketing authorisation to full marketing authorisation in the European Union
27 January 2023 - Pfizer today announced that the CHMP of the EMA has recommended converting the conditional marketing authorisation ...
Posted by Michael Wonder on 30 Nov 2022
European Commission grants expanded marketing authorisation for Gilead’s Biktarvy for the treatment of HIV in paediatric populations
29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...
Posted by Michael Wonder on 20 Sep 2022
Evusheld long-acting antibody combination approved in the EU for the treatment of COVID-19
20 September 2022 - Evusheld significantly reduced risk of severe COVID-19 or death in TACKLE Phase 3 treatment trial. ...
Posted by Michael Wonder on 16 Sep 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the treatment of COVID-19
16 September 2022 - Recommendation based on TACKLE Phase 3 treatment data showing reduced risk of severe COVID-19 or death. ...
Posted by Michael Wonder on 23 Aug 2022
European Medicines Agency commences review of oral fixed-dose combination of decitabine and cedazuridine for the treatment of adults with acute myeloid leukaemia
22 August 2022 - Otsuka and Astex Pharmaceuticals today announce that the EMA has accepted the marketing authorisation application for the ...