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RSS FeedPosted by Michael Wonder on 24 Feb 2022
EMA recommends authorisation of booster doses of Comirnaty from 12 years of age
24 February 2022 - EMA’s CHMP has recommended that a booster dose of the COVID-19 vaccine Comirnaty may be given where ...
Posted by Michael Wonder on 16 Feb 2022
Pfizer and OPKO’s once weekly Ngenla (somatrogon) injection receives marketing authorisation in European Union for treatment of paediatric growth hormone deficiency
15 February 2022 - Pfizer and OPKO Health announced today that the European Commission has granted marketing authorisation for the next ...
Posted by Michael Wonder on 08 Feb 2022
EMA evaluating data on booster dose of COVID-19 vaccine Comirnaty in adolescents
8 February 2022 - EMA has started evaluating an application for the use of a booster dose of Comirnaty (BioNTech/Pfizer’s vaccine) ...
Posted by Michael Wonder on 31 Jan 2022
CHMP recommends approval of Dupixent (dupilumab) for children aged 6 to 11 years with severe asthma with type 2 inflammation
31 January 2022 - Recommendation based on pivotal trial that showed Dupixent significantly reduced severe asthma attacks and improved lung function ...
Posted by Michael Wonder on 16 Jan 2022
Ascendis Pharma receives European Approval for TransCon hGH for paediatric growth hormone deficiency
13 January 2022 - TransCon hGH (approved by the European Commission as Lonapegsomatropin Ascendis Pharma) is a once-weekly prodrug of somatropin ...
Posted by Michael Wonder on 26 Dec 2021
Pfizer and BioNTech submit updated longer-term follow-up data of Comirnaty in adolescents 12 through 15 years of age to EMA
23 December 2021 - Pfizer and BioNTech today announced that they have submitted longer-term follow-up data from the companies’ pivotal Phase ...
Posted by Michael Wonder on 25 Nov 2021
Comirnaty COVID-19 vaccine: EMA recommends approval for children aged 5 to 11
25 November 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 13 Nov 2021
Vertex receives CHMP positive opinion for Kaftrio (ivacaftor/tezacaftor/elexacaftor) in combination with ivacaftor in children with cystic fibrosis ages 6 through 11
12 November 2021 - If approved, more than 1,500 children would be eligible for a medicine that can treat the ...
Posted by Michael Wonder on 10 Nov 2021
EMA starts evaluating use of COVID-19 vaccine Spikevax in children aged 6 to 11
10 November 2021 - EMA has started evaluating an application to extend the use of Moderna’s COVID-19 vaccine, Spikevax, to ...
Posted 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 ...