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RSS FeedPosted by Michael Wonder on 06 Jun 2025
Sydnexis announces European Commission approval of SYD-101, the first and only pharmaceutical treatment for slowing the progression of paediatric myopia
5 June 2025 - Exclusive licensing partner Santen will commercialise SYD-101 under the brand name Ryjunea in the EU. ...
Posted by Michael Wonder on 28 Mar 2025
Neurim Pharmaceuticals receives European marketing authorisation for paediatric prolonged-release melatonin (Slenyto) for the treatment of insomnia in children with ADHD
26 March 2025 - Neurim Pharmaceuticals announces that the European Commission has approved the extension of the indication to include ...
Posted by Michael Wonder on 03 Mar 2025
Vertex receives CHMP positive opinion for expanded label for Kaftrio in combination with ivacaftor for people with cystic fibrosis to include rare mutations
28 February 2025 - If approved, approximately 4,000 people with cystic fibrosis in the European Union will be eligible for ...
Posted by Michael Wonder on 01 Mar 2025
Valneva receives EMA’s positive CHMP opinion for adolescent label extension for chikungunya vaccine Ixchiq
28 February 2025 - If granted, Ixchiq will become the first vaccine against the chikungunya virus available in the EU ...
Posted by Michael Wonder on 07 Jan 2025
Norgine submits marketing authorisation application to the EMA for eflornithine (difluoromethylornithine) in high risk neuroblastoma
6 January 2025 - Norgine today announced that it completed its marketing authorisation application filing to the EMA for eflornithine in ...
Posted by Michael Wonder on 18 Dec 2024
ViiV Healthcare announces CHMP positive opinion for Vocabria + Rekambys, the first and only complete long-acting HIV treatment, for adolescents in Europe
16 December 2024 - Vocabria + Rekambys (cabotegravir + rilpivirine) is the first and only complete long-acting regimen for the treatment ...
Posted by Michael Wonder on 14 Dec 2024
First treatment recommended for rare progressive lung conditions in children and adolescents
13 December 2024 - The EMA has recommended extending the indication of Ofev (nintedanib) to include the treatment of progressive ...
Posted by Michael Wonder on 06 Nov 2024
Dupixent (dupilumab) approved in the European Union as the first and only medicine for young children with eosinophilic oesophagitis
6 November 2024 - Approval based on Phase 3 data showing significantly more children aged 1 to 11 years on ...
Posted by Michael Wonder on 20 Sep 2024
Dupixent (dupilumab) recommended for EU approval by the CHMP to treat eosinophilic oesophagitis in children as young as 1 year old
20 September 2024 - Recommendation based on a Phase 3 trial showing a significantly greater proportion of children on Dupixent achieved ...
Posted by Michael Wonder on 20 Sep 2024
Bavarian Nordic receives EMA approval of mpox vaccine for adolescents
19 September 2024 - MVA-BN approved for use against mpox and smallpox in adolescents 12-17 years of age after expedited review ...
Posted by Michael Wonder on 05 Jun 2024
Johnson & Johnson submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Prezcobix
4 June 2024 - Johnson & Johnson today announced the submission of a supplemental new drug application to the US FDA ...
Posted by Michael Wonder on 26 Apr 2024
Vertex announces European Commission approval for Kalydeco to treat infants with cystic fibrosis ages 1 month and older
26 April 2024 - Kalydeco is the first and only medicine approved in the EU in this age group to ...
Posted by Michael Wonder on 14 Mar 2024
European Commission approves Pfizer’s Prevenar 20 to help protect infants and children against pneumococcal disease
13 March 2024 - Prevenar 20 (20 valent pneumococcal conjugate vaccine) offers the broadest serotype coverage of any paediatric pneumococcal ...
Posted by Michael Wonder on 24 Feb 2024
Vertex receives CHMP positive opinion for Kalydeco for the treatment of infants with cystic fibrosis ages 1 month and older
23 February 2024 - If approved, Kalydeco will be the first and only medicine approved in Europe to treat the underlying ...
Posted by Michael Wonder on 18 Dec 2023
EMA recommends arpraziquantel for treatment of schistosomiasis in pre-school aged children
17 December 2023 - Astellas contributed to the development of a paediatric formulation to treat schistosomiasis as a member of ...