Blog
RSS FeedPosted by Michael Wonder on 02 Apr 2023
Novartis Entresto receives positive CHMP opinion for a heart failure
31 March 2023 - The positive opinion is based on final data from the 52 week Phase 3 PANORAMA-HF trial, the ...
Posted by Michael Wonder on 22 Mar 2023
Dupixent (dupilumab) approved by European Commission as first and only targeted medicine for children as young as six months old with severe atopic dermatitis
21 March 2023 - Milestone marks third Dupixent European Commission approval in the past four months. ...
Posted by Michael Wonder on 24 Feb 2023
ViiV Healthcare receives EU marketing authorisation for Triumeq PD, the first dispersible single tablet regimen containing dolutegravir, a once daily treatment for Children living with HIV in Europe
23 February 2023 - The authorisation is an important step to meet ViiV Healthcare’s commitment to bring paediatric formulations to children ...
Posted by Michael Wonder on 06 Feb 2023
Actions to support the development of medicines for children
6 February 2023 - Regulators in the European Union have taken several initiatives in the past four years to increase the ...
Posted by Michael Wonder on 23 Jan 2023
The EMA validated regulatory application for arpraziquantel, a potential treatment for schistosomiasis in pre-school aged children
23 January 2023 - Arpraziquantel is the first investigational drug in regulatory phase amongst the different projects supported by the Global ...
Posted by Michael Wonder on 04 Jan 2023
European Medicines Agency validates application for extension of indication for Vozogo (vosoritide) for injection to treat children with achondroplasia under the age of 2
4 January 2023 - BioMarin submits supplemental new drug application to US FDA to expand label to treat children with achondroplasia ...
Posted by Michael Wonder on 04 Dec 2022
EMA validates application for arpraziquantel to treat schistosomiasis in pre-school aged children
2 December 2022 - Merck, a leading science and technology company, and the Pediatric Praziquantel Consortium, today announced that the EMA ...
Posted by Michael Wonder on 30 Nov 2022
European Commission grants expanded marketing authorisation for Gilead’s Biktarvy for the treatment of HIV in paediatric populations
29 November 2022 - European Commission authorises a low dose tablet for HIV treatment in virologically suppressed children at least two ...
Posted by Michael Wonder on 11 Nov 2022
Pfizer and BioNTech receive positive CHMP opinion for Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine booster for children 5 through 11 years of age in European Union
10 November 2022 - Pfizer and BioNTech today announced a booster dose of their Omicron BA.4/BA.5-adapted bivalent COVID-19 vaccine (Comirnaty Original/Omicron ...
Posted by Michael Wonder on 21 Oct 2022
Leo Pharma announces European Commission approval of Adtralza (tralokinumab) for the treatment of moderate to severe atopic dermatitis in adolescents
20 October 2022 - Adtralza, a biologic that targets and neutralises the interleukin-13 cytokine, is now approved in Europe for adolescents ...
Posted by Michael Wonder on 19 Oct 2022
EMA recommends approval of Comirnaty and Spikevax COVID-19 vaccines for children from 6 months of age
19 October 2022 - The EMA’s CHMP has recommended extending the use of Comirnaty and Spikevax targeting the original strain ...
Posted 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 ...