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RSS FeedPosted 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. ...
Posted by Michael Wonder on 06 Apr 2023
Life changing cystic fibrosis treatment now available to children 6 years and above
6 April 2023 - From 1 May 2023, children aged 6 to 11 with cystic fibrosis will have access to ...
Posted by Michael Wonder on 05 Apr 2023
PHARMAC shares next steps in reviewing rule 8.1b
5 April 2023 - PHARMAC’s consultation on rule 8.1b of the Pharmaceutical Schedule has now closed. ...
Posted by Michael Wonder on 05 Apr 2023
‘An absolute game changer’: children under 12 to receive life saving drug
6 April 2023 - Hundreds of children with cystic fibrosis will have subsidised access to the life-changing medication Trikafta from ...
Posted by Michael Wonder on 04 Apr 2023
Koselugo approved in Canada for paediatric patients with neurofibromatosis type 1 plexiform neurofibromas
3 April 2023 - First and only therapy approved to treat this rare and debilitating genetic condition. ...
Posted 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 25 Mar 2023
NICE recommends life-changing gene therapy for children with ultra rare genetic disorder in final draft guidance
23 March 2023 - The first and currently only gene therapy for children with an ultra-rare genetic disorder has been recommended ...
Posted by Michael Wonder on 22 Mar 2023
FDA approves first in class Evkeeza (evinacumab-dgnb) for young children with ultra rare form of high cholesterol
22 March 2023 - Approval extends Evkeeza to children aged 5 to 11 with homozygous familial hypercholesterolaemia, an inherited condition characterised ...
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 17 Mar 2023
FDA approves dabrafenib with trametinib for paediatric patients with low grade glioma with a BRAF V600E mutation
16 March 2023 - Today, the FDA approved dabrafenib (Tafinlar, Novartis) with trametinib (Mekinist, Novartis) for paediatric patients 1 year ...
Posted by Michael Wonder on 15 Mar 2023
FDA authorises bivalent Pfizer-BioNTech COVID-19 vaccine as booster dose for certain children 6 months through 4 years of age
14 March 2023 - Today, the US FDA amended the emergency use authorisation of the Pfizer-BioNTech COVID-19 vaccine, bivalent to provide ...