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RSS FeedPosted 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 ...
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 ...