Blog
RSS FeedPosted by Michael Wonder on 22 Jun 2021
Koselugo approved in the EU for children with neurofibromatosis type 1 and plexiform neurofibromas
22 June 2021 - First medicine approved in the EU to treat this rare and debilitating genetic condition. ...
Posted by Michael Wonder on 18 Jun 2021
European Commission approves Aubagio (teriflunomide) as the first oral MS therapy for first-line treatment of children and adolescents living with relapsing-remitting multiple sclerosis
18 June 2021 - The European Commission has approved Aubagio (teriflunomide) for the treatment of paediatric patients 10 to 17 years ...
Posted by Michael Wonder on 08 Jun 2021
Moderna files for conditional marketing approval for its COVID-19 vaccine in adolescents in the European Union
7 June 2021 - Submission based on Phase 2/3 study of mRNA-1273 in adolescents ages 12 to less than 18 ...
Posted by Michael Wonder on 28 May 2021
First COVID-19 vaccine approved for children aged 12 to 15 in EU
28 May 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Comirnaty to include use ...
Posted by Michael Wonder on 03 May 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in young people aged 12 to 15
3 May 2021 - EMA has started evaluating an application to extend the use of the COVID-19 vaccine Comirnaty to ...
Posted by Michael Wonder on 26 Apr 2021
Selumetinib recommended for approval in the EU by CHMP as the first medicine for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
26 April 2021 - Recommendation based on the SPRINT Phase 2 trial, which showed selumetinib reduced tumour volume in children. ...
Posted by Michael Wonder on 29 Mar 2021
Saxenda recommended for approval by European Medicines Agency committee for the treatment of obesity in adolescents aged 12–17 years
26 March 2021 - Novo Nordisk today announced that the CHMP under the EMA has recommended that the use of Saxenda ...
Posted by Michael Wonder on 28 Feb 2021
EMA accepts marketing application for somatrogon to treat paediatric patients with growth hormone deficiency
26 February 2021 - If approved, somatrogon will serve as a once-weekly treatment option. ...
Posted by Michael Wonder on 14 Jan 2021
ViiV Healthcare receives EU marketing authorisation for the first-ever dispersible-tablet formulation of dolutegravir, Tivicay, a treatment for children living with HIV in Europe
13 January 2021 - Dolutegravir is the first integrase inhibitor available as a dispersible tablet for children weighing at least 3kg ...
Posted by Michael Wonder on 30 Nov 2020
Dupixent (dupilumab) approved by European Commission as first and only biologic medicine for children aged 6 to 11 years with severe atopic dermatitis
30 November 2020 - Pivotal trial showed more than four times as many children achieved itch reduction and more than three ...
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. ...
Posted by Michael Wonder on 16 Nov 2020
Eisai receives approval for indication expansion of anti-epileptic agent Fycompa for use in paediatric patients
16 November 2020 - Eisai announced that it has been received approval from the European Commission for the use of its ...
Posted by Michael Wonder on 13 Nov 2020
Angelini Pharma and Sunovion Pharmaceutical Europe receive EMA approval for Latuda, first atypical antipsychotic for the treatment of adolescent schizophrenia in patients starting from 13 years of age
12 November 2020 - Angelini Pharma and Sunovion Pharmaceutical Europe announced today the EMA approval for Latuda (lurasidone), with the indication ...
Posted by Michael Wonder on 05 Nov 2020
Vertex announces European Commission approval for Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with cystic fibrosis as early as four months of age
5 November 2020 - Approval provides opportunity to treat the underlying cause of cystic fibrosis earlier than ever before in Europe. ...
Posted by Michael Wonder on 18 Oct 2020
First treatment for rare condition primary hyperoxaluria type 1
16 October 2020 - EMA has recommended granting a marketing authorisation in the European Union for Oxlumo (lumasiran) for the ...