Blog
RSS FeedPosted by Michael Wonder on 04 May 2020
Vertex receives European CHMP positive opinion for Kalydeco (ivacaftor) for children and adolescents with cystic fibrosis between the ages 6 months and 18 years with the R117H mutation in the CFTR gene
1 May 2020 - If approved, Kalydeco (ivacaftor) will be the first and only medicine in Europe to treat the underlying ...
Posted by Michael Wonder on 28 Mar 2020
AveXis receives positive CHMP opinion for Zolgensma, the only gene therapy for spinal muscular atrophy
28 March 2020 - AveXis, a Novartis company, today announced that the CHMP of the EMA has adopted a positive ...
Posted by Michael Wonder on 12 Jan 2020
Sanofi secures expanded European approval for Toujeo in type 1 diabetes
10 January 2020 - Sanofi has revealed that the European Commission has expanded the existing label for Toujeo (insulin glargine ...
Posted by Michael Wonder on 11 Dec 2019
Vertex announces European Commission approval for Kalydeco (ivacaftor) in infants with cystic fibrosis ages 6 months to less than 12 months with certain mutations in the CFTR gene
10 December 2019 - Ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic ...
Posted by Michael Wonder on 30 Oct 2019
Intravenous Benlysta is the first biologic treatment to be approved for children with lupus in Europe
29 October 2019 - GlaxoSmithKline today announced that the European Commission has adopted a decision to extend to children five years ...
Posted by Michael Wonder on 22 Sep 2019
GSK receives positive CHMP opinion for intravenous Benlysta in children with lupus aged five years and above
20 September 2019 - GSK today announced that the EMA's CHMP has issued a positive opinion recommending the use of ...
Posted by Michael Wonder on 22 Aug 2019
Fiasp approved in Europe for the management of diabetes in adolescents and children aged one year and above
22 August 2019 - Novo Nordisk today announced that the European Commission has granted an extension of the indication for ...
Posted by Michael Wonder on 06 Aug 2019
Dupixent (dupilumab) approved by European Commission for adolescents with moderate-to-severe atopic dermatitis
6 August 2019 - Only biologic approved in the European Union for patients aged 12 and above with moderate-to-severe atopic dermatitis. ...
Posted by Michael Wonder on 26 Jul 2019
Novartis receives positive CHMP opinion for Lucentis treatment in preterm infants with retinopathy of prematurity, a disease causing visual impairment and blindness
26 July 2019 - Positive opinion is based on the landmark Phase III RAINBOW trial, which showed that Lucentis (ranibizumab) is ...
Posted by Michael Wonder on 01 Jul 2019
New treatment for children with type 2 diabetes mellitus
28 June 2019 - EMA’s CHMP has recommended granting an extension of indication to Victoza (liraglutide) to include the treatment of ...
Posted by Michael Wonder on 14 Feb 2019
Eisai submits application in Europe seeking approval for Fycompa as treatment for paediatric patients with epilepsy
13 February 2019 - Eisai announced today that it has submitted an application to the EMA for its in-house discovered ...
Posted by Michael Wonder on 11 Feb 2019
European Commission approves Bristol-Myers Squibb’s Sprycel (dasatinib) in combination with chemotherapy for treatment of paediatric patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukaemia
11 February 2019 - Bristol-Myers Squibb today announced that the European Commission has approved Sprycel (dasatinib) in combination with chemotherapy ...
Posted by Michael Wonder on 22 Jan 2019
Vertex announces European Commission approval for Orkambi (lumacaftor/ivacaftor) for treatment of children with cystic fibrosis aged 2 to 5 years old with most common form of the disease
21 January 2019 - Lumacaftor/ivacaftor is the first and only approved medicine in Europe to treat the underlying cause of cystic ...
Posted by Michael Wonder on 14 Jan 2019
EMA approves Flutiform for children with asthma
14 January 2019 - The EMA has approved Flutiform pMDI for use in the treatment of children with asthma aged ...
Posted by Michael Wonder on 17 Dec 2018
Bristol-Myers Squibb receives positive CHMP opinion recommending Sprycel (dasatinib) for paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia
17 December 2018 - Bristol-Myers Squibb today announced that the CHMP of the EMA has recommended the expanded approval of ...