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RSS FeedPosted by Michael Wonder on 10 Mar 2023
Alberta’s import of children’s medication to cost taxpayers $80 million
9 March 2023 - Alberta taxpayers are on the hook for $80 million, after Health Minister Jason Copping finally revealed ...
Posted by Michael Wonder on 08 Mar 2023
US FDA accepts supplemental new drug application for Jardiance for children 10 years and older with type 2 diabetes
8 March 2023 - The application is based on phase III results from the DINAMO trial showing Jardiance (empagliflozin) tablets significantly ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts Mesoblast’s resubmission of the biologic license application for remestemcel-L in children with steroid-refractory acute graft versus host disease as a complete response
7 March 2023 - If approved, remestemcel-L will be the first allogeneic “off the shelf” cellular medicine in the US and ...
Posted by Michael Wonder on 08 Mar 2023
FDA accepts BioMarin's supplemental new drug application to expand use of Voxzogo (vosoritide) for injection to treat children with achondroplasia under the age of 5
7 March 2023 - FDA set PDUFA target action date of 21 October 2023. ...
Posted by Michael Wonder on 01 Mar 2023
Pfizer and BioNTech submit for US emergency use authorisation of Omicron BA.4/BA.5 adapted bivalent COVID-19 booster in children under 5 years
1 March 2023 - Pfizer and BioNTech today submitted an application to the US FDA for emergency use authorisation of ...
Posted by Michael Wonder on 28 Feb 2023
PHARMAC will fund meningococcal B vaccine for babies, teens and young people
28 February 2023 - From Wendesday, PHARMAC will fund meningococcal B vaccine for a number of potentially at-risk groups including ...
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 19 Feb 2023
Health Canada authorises Moderna's Omicron targeting bivalent COVID-19 vaccine in children & adolescents (6-17 years)
17 February 2023 - The recommendation is based on clinical data for Moderna's bivalent Omicron targeting COVID-19 vaccine, mRNA.1273.214. ...
Posted by Michael Wonder on 17 Feb 2023
UK’s most expensive drug Libmeldy saved Teddi Shaw, but is too late for her sister
16 February 2023 - A toddler with a rare inherited condition has become the first child to be treated by ...
Posted by Michael Wonder on 13 Feb 2023
Ironwood Pharmaceuticals announces FDA filing acceptance and priority review of supplemental new drug application for Linzess (linaclotide) for functional constipation in children and adolescents ages 6-17 years old
13 February 2023 - FDA assigns second quarter 2023 target action date. ...
Posted by Michael Wonder on 11 Feb 2023
Health Canada approves Adtralza (tralokinumab) for the treatment of adolescents aged 12 to 17 with moderate to severe atopic dermatitis
8 February 2023 - Adtralza is the first treatment for adolescents with moderate to severe atopic dermatitis specifically targeting the ...
Posted by Michael Wonder on 10 Feb 2023
FDA approves Pfizer's supplemental new drug application for Cibinqo (abrocitinib)
10 February 2023 - Label expansion for Cibinqo provides new systemic oral option for adolescents (12 to <18 years) with ...
Posted by Michael Wonder on 09 Feb 2023
Digital mental health tech for children and young people recommended by NICE in first rapid healthtech guidance
8 February 2023 - Four digital technologies that can help children and young people with mild to moderate symptoms of anxiety ...
Posted by Michael Wonder on 09 Feb 2023
NICE recommends genetic test to prevent newborn babies going deaf
9 February 2023 - A genetic test to establish if a newborn baby is vulnerable to deafness if treated with a ...
Posted by Michael Wonder on 09 Feb 2023
Eylea (aflibercept) injection approved as the first pharmacological treatment for preterm infants with retinopathy of prematurity by the FDA
8 February 2023 - Eylea now approved to treat five retinal conditions caused by ocular angiogenesis. ...