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RSS FeedPosted by Michael Wonder on 30 Aug 2023
European Commission approves Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
29 August 2023 - Approval is based on interim data from ongoing RAINBOWFISH trial showing majority of Evrysdi-treated babies were able ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 27 Jul 2023
Soliris approved in the EU for children and adolescents with refractory generalised myasthenia gravis
27 July 2023 - First and only targeted therapy approved for paediatric patients with generalised myasthenia gravis in the EU ...
Posted by Michael Wonder on 24 Jul 2023
First RSV vaccine to protect infants up to 6 months of age and older adults
21 July 2023 - EMA has recommended granting a marketing authorisation in the European Union for Abrysvo, a vaccine to protect ...
Posted by Michael Wonder on 22 Jul 2023
CHMP recommends Roche’s Evrysdi for babies under two months old with spinal muscular atrophy
21 July 2023 - Positive recommendation is based on interim data from ongoing RAINBOWFISH trial which showed majority of Evrysdi treated ...
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 26 Jun 2023
Soliris recommended for approval in the EU by CHMP for children and adolescents with refractory generalised myasthenia gravis
26 June 2023 - The first in class C5 inhibitor reduced disease severity and symptoms with sustained improvements over 26 ...
Posted by Michael Wonder on 20 Jun 2023
Legacy Healthcare announces EMA validation of marketing authorisation application for coacillium for the treatment of moderate and severe alopecia areata in children and adolescents
19 June 2023 - Legacy Healthcare today announced that its marketing authorisation application to the EMA's CHMP for Coacillium for the ...
Posted by Michael Wonder on 06 Jun 2023
Fennec Pharmaceuticals announces European Commission marketing authorisation for Pedmarqsi (sodium thiosulphate) to reduce the risk of hearing loss in paediatric oncology patients
6 June 2023 - Pedmarqsi is the first and only approved therapy in the European Union for reducing the risk of ...
Posted by Michael Wonder on 29 May 2023
Once weekly Sogroya (somapacitan) receives CHMP positive opinion for expanded use in children and adolescents with growth hormone deficiency
26 May 2023 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending once weekly Sogroya ...
Posted by Michael Wonder on 02 Apr 2023
Novartis Entresto receives positive CHMP opinion for a heart failure
31 March 2023 - The positive opinion is based on final data from the 52 week Phase 3 PANORAMA-HF trial, the ...
Posted by Michael Wonder on 22 Mar 2023
Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...
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 06 Feb 2023
Actions to support the development of medicines for children
6 February 2023 - Regulators in the European Union have taken several initiatives in the past four years to increase the ...
Posted by Michael Wonder on 23 Jan 2023
The EMA validated regulatory application for arpraziquantel, a potential treatment for schistosomiasis in pre-school aged children
23 January 2023 - Arpraziquantel is the first investigational drug in regulatory phase amongst the different projects supported by the Global ...