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RSS FeedPosted by Michael Wonder on 09 Nov 2021
Moderna files to expand the conditional marketing authorisation for its COVID-19 vaccine in the European Union to include children ages 6-11 years
9 November 2021 - Submission based on Phase 2/3 study of mRNA-1273 in children ages 6 to 11. ...
Posted by Michael Wonder on 18 Oct 2021
EMA starts evaluating use of COVID-19 vaccine Comirnaty in children aged 5 to 11
18 October 2021 - EMA has started evaluating an application to extend the use of BioNTech/Pfizer’s COVID-19 vaccine, Comirnaty, to ...
Posted by Michael Wonder on 03 Sep 2021
Ultomiris approved in the EU for children and adolescents with paroxysmal nocturnal haemoglobinuria
3 September 2021 - Approval based on interim results from Phase 3 trial demonstrating complete terminal complement inhibition with reduced ...
Posted by Michael Wonder on 28 Aug 2021
European Commission approves BioMarin's Voxzogo (vosoritide) for the treatment of children with achondroplasia from age 2 until growth plates close
27 August 2021 - First medicine approved to treat children with achondroplasia in Europe ...
Posted by Michael Wonder on 03 Aug 2021
Mustang Bio receives European Medicines Agency PRIME designation for MB-107 to treat X-linked severe combined immunodeficiency in newly diagnosed infants
2 August 2021 - Mustang Bio today announced that the EMA has granted Priority Medicines designation to MB-107, its lentiviral ...
Posted by Michael Wonder on 03 Aug 2021
Amicus Therapeutics announces European Commission approval of Galafold (migalastat) for adolescents with Fabry disease
2 August 2021 - Galafold is the first and only oral therapy approved in the EU for the long-term treatment of ...
Posted by Michael Wonder on 26 Jul 2021
Ultomiris recommended for approval in the EU by CHMP for children and adolescents with paroxysmal nocturnal haemoglobinuria
26 July 2021 - Opinion based on results from Ultomiris Phase 3 trial that showed an established efficacy and safety ...
Posted by Michael Wonder on 24 Jul 2021
COVID-19 vaccine Spikevax approved for children aged 12 to 17 in EU
23 July 2021 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Spikevax (previously COVID-19 Vaccine ...
Posted by Michael Wonder on 22 Jul 2021
bluebird bio receives EC approval for Skysona (elivaldogene autotemcel, Lenti-D) gene therapy for patients less than 18 years of age with early cerebral adrenoleukodystrophy without matched sibling donor
21 July 2021 - Skysona is the first and only gene therapy approved in the European Union to treat early CALD. ...
Posted 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. ...