Blog
RSS FeedPosted by Michael Wonder on 24 Mar 2022
Evusheld long-acting antibody combination recommended for approval in the EU for the pre-exposure prophylaxis of COVID-19
24 March 2022 - Recommendation based on Phase 3 PROVENT trial showing a significant reduction in the risk of developing ...
Posted by Michael Wonder on 28 Feb 2022
Amylyx Pharmaceuticals announces EMA validation of marketing authorisation application for AMX0035 for the treatment of ALS
25 February 2022 - Amylyx Pharmaceuticals today announced that its marketing authorisation application to the EMA CHMP for AMX0035 (sodium phenylbutyrate ...
Posted by Michael Wonder on 27 Jan 2022
COVID-19: EMA recommends conditional marketing authorisation for Paxlovid
27 January 2022 - The EMA’s CHMP has recommended granting a conditional marketing authorisation for the oral antiviral medicine Paxlovid ...
Posted by Michael Wonder on 11 Jan 2022
European Commission approves Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor to treat children with cystic fibrosis ages 6 to 11 years
11 January 2022 - More than 1,500 children now eligible to receive a treatment targeting the underlying cause of cystic ...
Posted by Michael Wonder on 10 Jan 2022
EMA receives application for conditional marketing authorisation for Paxlovid (PF-07321332 and ritonavir) for treating patients with COVID-19
10 January 2022 - EMA has started evaluating an application for a conditional marketing authorisation for the oral antiviral medicine ...
Posted by Michael Wonder on 05 Jan 2022
Amylyx Pharmaceuticals submits marketing authorisation application for AMX0035 for the Treatment of ALS
4 January 2022 - Amylyx Pharmaceuticals today announced it has submitted a marketing authorisation application to the EMA's CHMP for ...
Posted by Michael Wonder on 24 May 2021
Positive CHMP opinion for Ryeqo (relugolix combination tablet)
21 May 2021 - Gedeon Richter announces that the CHMP of the EMA has adopted a positive opinion recommending approval of ...
Posted by Michael Wonder on 20 May 2021
EMA, MHRA to review Vertex' Kaftrio for children with cystic fibrosis
20 May 2021 - The EMA and the MHRA have validated Vertex' applications to expand the scope of its cystic ...
Posted by Michael Wonder on 02 Feb 2021
Chiesi Group receives the European Marketing authorization for the extrafine triple-combination therapy for the treatment of moderate to severe asthma
1 February 2021 - It is the first extrafine fixed triple combination therapy in a single inhaler to be approved for ...
Posted by Michael Wonder on 01 Feb 2021
EMA starts rolling review of REGN-COV2 antibody combination (casirivimab/imdevimab)
1 February 2021 - EMA’s human medicines committee (CHMP) has started a ‘rolling review’ of data on a medicine known ...
Posted by Michael Wonder on 12 Jan 2021
Aerie Pharmaceuticals receives European Commission approval for Roclanda (netarsudil and latanoprost ophthalmic solution) 0.02%/0.005%
11 January 2021 - Aerie Pharmaceuticals today announced the European Commission has granted a marketing authorisation for Roclanda (netarsudil and latanoprost ...
Posted by Michael Wonder on 22 Dec 2020
ViiV Healthcare announces the marketing authorisation of the first complete long-acting injectable HIV treatment in Europe
21 December 2020 - Marketing authorisation granted by European Commission for ViiV Healthcare’s Vocabria (cabotegravir injection and tablets) to be used ...
Posted by Michael Wonder on 14 Dec 2020
Trixeo Aerosphere approved in the EU for maintenance treatment of COPD
14 December 2020 - Fourth major approval for AstraZeneca’s triple-combination therapy which is marketed as Breztri Aerosphere in the US, ...
Posted by Michael Wonder on 14 Dec 2020
Advicenne receives positive CHMP opinion recommending approval of ADV7103 (sibnayal) for the treatment of distal renal tubular acidosis
11 December 2020 - Advicenne today announces the CHMP of the EMA adopted a positive opinion recommending approval of its lead ...
Posted by Michael Wonder on 28 Nov 2020
Vertex announces European Commission approval for Symkevi (tezacaftor/ivacaftor) with Kalydeco (ivacaftor) for eligible children with cystic fibrosis ages 6-11 years
27 November 2020 - The combination therapy is a new treatment option for CF patients who are homozygous for F508del. ...