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RSS FeedPosted by Michael Wonder on 17 Sep 2022
Merck receives positive CHMP opinion for Vaxneuvance (pneumococcal 15 valent conjugate vaccine) in infants and children
16 February 2022 - Merck announced today that the EMA’s CHMP has recommended the approval of Vaxneuvance (pneumococcal 15 valent conjugate ...
Posted by Michael Wonder on 17 Sep 2022
Leo Pharma receives positive CHMP opinion of Adtralza (tralokinumab) for the treatment of adolescents with moderate to severe atopic dermatitis
16 September 2022 - Recommendation supported by data from the Phase 3 ECZTRA 6 trial. ...
Posted by Michael Wonder on 17 Sep 2022
CHMP adopts positive opinion to extend indication of Veklury (remdesivir) for the treatment of paediatric patients with COVID-19
16 September 2022 - If granted by the European Commission, Veklury will become the first and only authorised anti-viral treatment for ...
Posted by Michael Wonder on 23 Jul 2022
EMA CHMP recommends use of the Moderna COVID-19 booster in adolescents (12-17 Years) in the European Union
22 July 2022 - Moderna today announced that the EMA's CHMP has adopted a positive opinion recommending a variation to ...
Posted by Michael Wonder on 19 Jul 2022
EU regulator reviews Pfizer-BioNTech COVID shot in children as young as 6 months
18 July 2022 - The European Medicines Agency on Monday started reviewing a low-dose version of BioNTech and Pfizer’s COVID-19 ...
Posted by Michael Wonder on 10 Jul 2022
Novavax Nuvaxovid COVID-19 vaccine conditionally authorised in the European Union for adolescents aged 12 through 17
5 July 2022 - Nuvaxovid COVID-19 vaccine is the first protein-based option for adolescents aged 12 through 17 in Europe. ...
Posted by Michael Wonder on 10 Jul 2022
Pfizer and BioNTech submit a variation to EMA for the vaccination of children 6 months to less than 5 years with Comirnaty
8 July 2022 - y 8, 2022 — Pfizer and BioNTech today announced that the companies have submitted a variation to ...
Posted by Michael Wonder on 28 Jun 2022
Cosentyx (secukinumab) receives expanded approvals in EU for use in childhood arthritic conditions
27 June 2022 - Approvals based on data from the JUNIPERA trial, showing that Cosentyx® (secukinumab) reduced the risk of flare ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends Valneva’s COVID-19 vaccine for authorisation in the EU
23 June 2022 - EMA has recommended granting a marketing authorisation for COVID-19 Vaccine (inactivated, adjuvanted) Valneva for use in ...
Posted by Michael Wonder on 23 Jun 2022
EMA recommends authorisation of Nuvaxovid for adolescents aged 12 to 17
23 June 2022 - EMA’s CHMP has recommended granting an extension of indication for the COVID-19 vaccine Nuvaxovid to include use ...
Posted by Michael Wonder on 09 Jun 2022
Bydureon BCise (exenatide prolonged-release) approved in the EU for paediatric patients with type 2 diabetes
8 June 2022 - First once weekly GLP-1 treatment option for paediatric patients with type-2 diabetes in the EU. ...
Posted by Michael Wonder on 21 May 2022
PTC Therapeutics receives positive CHMP opinion for Upstaza for the treatment of AADC deficiency
20 May 2022 - First ever gene therapy directly administered into the brain. ...
Posted by Michael Wonder on 20 May 2022
Novartis Cosentyx (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions
20 May 2022 - Positive opinion could expand the role of Cosentyx (secukinumab) in reducing flare risk in paediatric enthesitis-related arthritis ...
Posted by Michael Wonder on 07 Apr 2022
Dupixent (dupilumab) approved by European Commission for children aged 6 to 11 years with severe asthma with type 2 inflammation
7 April 2022 - Approval based on Phase 3 data showing Dupixent significantly reduced severe asthma attacks and also improved lung ...
Posted by Michael Wonder on 31 Mar 2022
Novavax submits request to expand conditional marketing authorisation of COVID-19 vaccine in the European Union to adolescents (ages 12-17)
31 March 2022 - If granted, Nuvaxovid COVID-19 vaccine (recombinant, adjuvanted) would be the first protein-based option for adolescents aged ...