Blog
RSS FeedPosted by Michael Wonder on 06 Jan 2023
AUM Biosciences receives US FDA rare paediatric disease designation for AUM302 for treatment of neuroblastoma
5 January 2023 - AUM Biosciences announced today that the US FDA has granted a rare paediatric disease designation for its ...
Posted by Michael Wonder on 05 Jan 2023
Nirsevimab US regulatory submission accepted for the prevention of RSV lower respiratory tract disease in infants and children up to age 24 months
5 January 2023 - Submission supported by comprehensive clinical trial programme, which demonstrated protection against RSV disease through the RSV ...
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 30 Dec 2022
FDA approves once weekly Wegovy injection for the treatment of obesity in teens aged 12 years and older
24 December 2022 - New indication based on clinical trial that demonstrated a 16.1% reduction in body mass index (BMI) in ...
Posted by Michael Wonder on 22 Dec 2022
NICE recommends a weekly injection for treating growth failure in children
22 December 2022 - This recommendation comes from a pilot to develop simpler, faster evaluations for the appraisal of some treatments. ...
Posted by Michael Wonder on 18 Dec 2022
EQ-5D-Y-3L value sets, valuation methods and conceptual questions
12 December 2022 - The measurement and valuation of child health-related quality of life is a rapidly evolving field. ...
Posted by Michael Wonder on 17 Dec 2022
AbbVie submits supplemental new drug application to US FDA to support new indication of Linzess (linaclotide) for functional constipation in children and adolescents 6 to 17 years of age
16 December 2022 - Submission is based on positive Phase 3 study data demonstrating linaclotide (72 mcg) resulted in increases ...
Posted by Michael Wonder on 15 Dec 2022
Children, parents protest PHARMAC funding review at Parliament
14 December 2022 - A petition calling on PHARMAC to "fund lifesaving medicines for all New Zealand children" has been ...
Posted by Michael Wonder on 13 Dec 2022
PHARMAC petition: fear tamariki with cancer won’t have access to lifesaving medicines
13 December 2022 - A petition, that will be delivered tomorrow to Parliament, on behalf of Tamariki with cancer, chronic ...
Posted by Michael Wonder on 10 Dec 2022
Health Canada authorises the Pfizer-BioNTech Omicron BA.4/BA.5 bivalent adapted COVID-19 booster for children 5 to 11 years of age
9 December 2022 - Today, Health Canada authorised the Pfizer-BioNTech Comirnaty Omicron BA.4/BA.5 bivalent adapted booster for use in children 5 ...
Posted by Michael Wonder on 08 Dec 2022
FDA authorises updated (bivalent) COVID-19 vaccines for children down to 6 months of age
8 December 2022 - Today, the US FDA amended the emergency use authorisations of the updated (bivalent) Moderna and Pfizer-BioNTech COVID-19 ...
Posted by Michael Wonder on 07 Dec 2022
Novavax Nuvaxovid COVID-19 vaccine approved in Canada for use as a primary series in adolescents
7 December 2022 - Novavax today announced that Health Canada has approved a supplement to a new drug submission for Nuvaxovid ...
Posted by Michael Wonder on 06 Dec 2022
Pfizer and BioNTech submit application to US FDA for emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 vaccine in children under 5 years
5 December 2022 - Pfizer andBioNTech today announced that the companies have submitted an application to the US FDA for ...
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 ...