Blog
RSS FeedPosted by Michael Wonder on 06 Jun 2023
Fennec Pharmaceuticals announces European Commission marketing authorisation for Pedmarqsi (sodium thiosulphate) to reduce the risk of hearing loss in paediatric oncology patients
6 June 2023 - Pedmarqsi is the first and only approved therapy in the European Union for reducing the risk of ...
Posted by Michael Wonder on 06 Jun 2023
Vyluma announces FDA acceptance of new drug application for NVK002, its novel investigational treatment for paediatric myopia
6 June 2023 – Vyluma announced today that the US FDA has accepted for review the new drug application for ...
Posted by Michael Wonder on 02 Jun 2023
AD treatment Dupixent approved for use in China for young children
31 May 2023 - Sanofi announced on Tuesday that Dupixent, the world's first targeted biological agent for atopic dermatitis treatment, ...
Posted by Michael Wonder on 29 May 2023
Once weekly Sogroya (somapacitan) receives CHMP positive opinion for expanded use in children and adolescents with growth hormone deficiency
26 May 2023 - Novo Nordisk today announced that the EMA's CHMP has adopted a positive opinion, recommending once weekly Sogroya ...
Posted by Michael Wonder on 16 May 2023
RACGP welcomes asthma puffer decision saving Aussie families time and money
15 May 2023 - The Royal Australian College of GPs (RACGP) has welcomed the PBAC's decision to remove limitations requiring ...
Posted by Michael Wonder on 16 May 2023
FDA grants SiSaf’s innovative siRNA therapy SIS-101-ADO orphan drug designation and rare paediatric disease designation for the treatment of autosomal dominant osteopetrosis
15 May 2023 - SiSaf announces that SIS-101-ADO, its siRNA therapeutic, has been granted orphan drug designation and rare paediatric disease ...
Posted by Michael Wonder on 15 May 2023
Caldolor now FDA approved for treatment of fever & pain in infants
15 May 2023 - Caldolor is the only injectable non-opioid approved for treating pain in infants. ...
Posted by Michael Wonder on 12 May 2023
PBAC backs ongoing access to low-dose asthma puffer for Aussie kids
12 May 2023 - The independent, expert group advising the Australian Government on PBS medications has reviewed its recommendation to put ...
Posted by Michael Wonder on 08 May 2023
Koselugo approved in China for paediatric patients with neurofibromatosis type 1 and plexiform neurofibromas
8 May 2023 - First and only approved treatment in China for rare and progressive genetic condition, which can result ...
Posted by Michael Wonder on 03 May 2023
Vertex announces US FDA approval for Kalydeco (ivacaftor) to treat eligible infants with CF ages 1 month and older
3 May 2023 - First and only CFTR modulator approved for this age group. ...
Posted by Michael Wonder on 28 Apr 2023
US FDA approves Prevnar 20, Pfizer’s 20 valent pneumococcal conjugate vaccine for infants and children
27 April 2023 - Prevnar 20 offers the broadest serotype coverage of any pediatric pneumococcal conjugate vaccine, helping to protect ...
Posted by Michael Wonder on 26 Apr 2023
Vertex announces US FDA approval for Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) in children with cystic fibrosis ages 2 through 5 with certain mutations
26 April 2023 - About 900 children with cystic fibrosis will now have a medicine to treat the underlying cause of ...
Posted by Michael Wonder on 24 Apr 2023
Health Canada approves new antibody drug to help prevent serious RSV in babies
22 April 2023 - Health Canada has approved a new antibody drug to help protect babies from serious illness caused ...
Posted by Michael Wonder on 13 Apr 2023
Vertex announces Health Canada market authorisation for Orkambi (lumacaftor/ivacaftor) in children with cystic fibrosis ages 1 to <2 years
10 April 2023 - With this approval, approximately 30 children with two copies of the F508del mutation are eligible for ...
Posted by Michael Wonder on 12 Apr 2023
Takeda receives FDA approval to expand the use of Hyqvia to treat primary immunodeficiency in children
11 April 2023 - Approval supported by pivotal Phase 3 study that demonstrated reliable infection protection in children 2-16 years pld. ...