Blog
RSS FeedPosted by Michael Wonder on 23 Sep 2020
Eisai receives positive opinion from EMA's CHMP on use of anti-epileptic agent Fycompa in paediatric patients
23 September 2020 - Eisai announced that it has received a positive opinion from the EMA’s CHMP on the license extension ...
Posted by Michael Wonder on 22 Sep 2020
CHMP grants positive opinion for expanded use of Otsuka’s Deltyba (delamanid) in children and adolescents weighing at least 30 kg treated for pulmonary multi-drug resistant tuberculosis
21 September 2020 - This label extension of Deltyba (delamanid) represents a new treatment option for children and adolescents with pulmonary ...
Posted by Michael Wonder on 03 Aug 2020
Novartis Cosentyx receives EU approval for first-line systemic treatment in paediatric psoriasis
3 August 2020 - EU approval is based on two Phase III studies showing Cosentyx provides fast and strong skin clearance, ...
Posted by Michael Wonder on 24 Jul 2020
BioMarin submits marketing authorisation application to European Medicines Agency for vosoritide to treat children with achondroplasia
23 July 2020 - If approved, vosoritide would be the first medicine to treat Achondroplasia in EU. ...
Posted by Michael Wonder on 28 Jun 2020
Novartis Cosentyx gains positive CHMP opinion for paediatric psoriasis, reinforcing established efficacy and safety profile
26 June 2020 - EMA CHMP positive opinion paves way for Cosentyx to become a first-line systemic treatment in paediatric psoriasis. ...
Posted 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 ...