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RSS FeedPosted by Michael Wonder on 11 Sep 2025
Health Canada approves Slenyto - extended-release melatonin formulation - as a prescription drug for insomnia in children with autism spectrum disorder and Smith-Magenis syndrome
10 September 2025 - Neurim Pharmaceuticals is pleased to announce that Health Canada has granted marketing authorisation for Slenyto, an ...
Posted by Michael Wonder on 10 Sep 2025
FDA approves selumetinib for pediatric patients 1 year of age and older with neurofibromatosis type 1 with symptomatic, inoperable plexiform neurofibromas
10 September 2025 - Today, the FDA approved selumetinib (Koselugo, AstraZeneca Pharmaceuticals) granules and capsules for paediatric patients 1 year ...
Posted by Michael Wonder on 19 Aug 2025
Valneva’s chikungunya vaccine Ixchiq now authorised in Canada for individuals aged 12 and plder
18 August 2025 - Valneva today announced that Health Canada has granted marketing authorisation for its single dose vaccine, Ixchiq, ...
Posted by Michael Wonder on 18 Aug 2025
Marketing authorisation application for CT001 has been submitted to the EMA for acute pain management in children
14 August 2025 - The marketing authorisation application for CT001 is submitted to the EMA for acute pain management in ...
Posted by Michael Wonder on 26 Jul 2025
Sobi announces US FDA approves Doptelet (avatrombopag) for the treatment of thrombocytopenia in paediatric patients one year and older with persistent or chronic immune thrombocytopenia
25 July 2025 - The primary outcome was met in 27.8% of patients, confirming the efficacy in children and adolescents ...
Posted by Michael Wonder on 15 Jul 2025
Health Canada extends the approval of Evkeeza (evinacumab) to children as young as 6 months old with homozygous familial hypercholesterolaemia
14 July 2025 - Ultragenyx today announced that Health Canada has extended the approval of Evkeeza (evinacumab) as an adjunct to ...
Posted by Michael Wonder on 15 Jul 2025
Moderna receives full US FDA approval for COVID-19 vaccine, Spikevax, in children aged 6 months through 11 years at increased risk for COVID-19 disease
10 July 2025 - Spikevax is now approved for all adults aged 65 years and older, and individuals aged 6 ...
Posted by Michael Wonder on 11 Jul 2025
Swissmedic approves Ifinwil (eflornithine) for children diagnosed with high-risk neuroblastoma
8 July 2025 - Norgine is pleased to announce that Swissmedic has approved the registration of Ifinwil (eflornithine) as monotherapy ...
Posted by Michael Wonder on 26 Jun 2025
Precision BioSciences receives FDA rare paediatric disease designation for PBGENE-DMD for the treatment of Duchenne muscular dystrophy
25 June 2025 - Precision BioSciences today announced that the US FDA has granted rare paediatric disease designation for PBGENE-DMD for ...
Posted by Michael Wonder on 25 Jun 2025
Quoin Pharmaceuticals announces FDA grants rare paediatric disease designation for QRX003 in Netherton syndrome
24 June 2025 - Quoin Pharmaceuticals today announced that the US FDA has granted rare paediatric disease designation for the ...
Posted by Michael Wonder on 25 Jun 2025
FDA approves Benlysta (belimumab) auto-injector for children with active lupus nephritis
24 June 2025 - With this approval, paediatric patients aged five years and older with active lupus nephritis will have ...
Posted by Michael Wonder on 18 Jun 2025
Johnson & Johnson seeks US FDA approval of Stelara (ustekinumab) for the treatment of paediatric Crohn’s disease
17 June 2025 - Supported by 52 week data from the Phase 3 UNITI-Jr study, submission aims to expand Stelara indication ...
Posted by Michael Wonder on 16 Jun 2025
Celltrion announces US FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients
15 June 2025 - Approval of 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection expands dosing flexibility for ...
Posted by Michael Wonder on 06 Jun 2025
Sydnexis announces European Commission approval of SYD-101, the first and only pharmaceutical treatment for slowing the progression of paediatric myopia
5 June 2025 - Exclusive licensing partner Santen will commercialise SYD-101 under the brand name Ryjunea in the EU. ...
Posted by Michael Wonder on 02 Jun 2025
FDA accepts TransCon CNP NDA for priority review
2 June 2025 - Ascendis Pharma today announced that the US FDA has accepted for priority review its new drug application ...