Blog
RSS FeedPosted by Michael Wonder on 03 Aug 2023
US FDA approves Merck’s Ervebo (Ebola Zaire vaccine, live) for use in children 12 months of age and older
3 August 2023 - Merck continues progress in helping to protect people at risk of Zaire ebolavirus disease. ...
Posted by Michael Wonder on 28 Jul 2023
Janssen submits supplemental new drug application to US FDA seeking expanded paediatric indication for HIV-1 therapy Edurant
28 July 2023 - Parallel application also submitted to European Medicines Agency. ...
Posted by Michael Wonder on 25 Jul 2023
US FDA accepts supplemental new drug application for Ofev (nintedanib) for children and adolescents aged 6-17 years old with fibrosing interstitial lung disease
25 July 2023 - The supplemental new drug application is based on results from the InPedILD Phase III trial, which assessed ...
Posted by Michael Wonder on 20 Jul 2023
Advent Therapeutics receives FDA rare paediatric disease designation for retinol palmitate for prevention of bronchopulmonary dysplasia in premature infants
20 July 2023 - Advent plans FDA PDUFA meeting late 2023 to establish pathway for US approval of lead injectable ...
Posted by Michael Wonder on 17 Jul 2023
FDA approves new drug to prevent RSV in babies and toddlers
17 July 2023 - Today, the US FDA approved Beyfortus (nirsevimab-alip) for the prevention of respiratory syncytial virus lower respiratory tract ...
Posted by Michael Wonder on 10 Jul 2023
MyoPax receives rare paediatric disease designation from FDA for breakthrough regenerative cell product in exstrophy-epispadias complex
10 July 2023 - The US FDA granted a rare paediatric Disease designation to MyoPax.. ...
Posted by Michael Wonder on 07 Jul 2023
FDA grants rare paediatric disease designation to NS-089/NCNP-02 for the treatment of Duchenne muscular dystrophy
7 July 2023 - NS Pharma announced today the US FDA has granted rare paediatric disease designation to NS-089/NCNP-02 (brogidirsen) an ...
Posted by Michael Wonder on 06 Jul 2023
IPS Heart receives US FDA rare paediatric drug designation for ISX9-CPC stem cell therapy for treatment of cardiomyopathy associated with Danon disease
6 July 2023 - Marks third rare paediatric drug designation granted by FDA for pipeline candidate. ...
Posted by Michael Wonder on 28 Jun 2023
FDA approves Pfizer’s Ngenla, a long-acting once weekly treatment for paediatric growth hormone deficiency
28 June 2023 - New, longer-acting treatment offers option to reduce the frequency of injections for children with growth hormone ...
Posted by Michael Wonder on 22 Jun 2023
FDA approves first gene therapy for treatment of certain patients with Duchenne muscular dystrophy
22 June 2023 - Today, the US FDA approved Elevidys, the first gene therapy for the treatment of pediatric patients 4 ...
Posted by Michael Wonder on 20 Jun 2023
FDA approves new class of medicines to treat paediatric type 2 diabetes
20 June 2023 - Today, the US FDA approved Jardiance (empagliflozin) and Synjardy (empagliflozin and metformin hydrochloride) as additions to diet ...
Posted by Michael Wonder on 15 Jun 2023
FDA accepts for review Medexus's IXinity supplemental biological license application for paediatric patients
15 June 2023 - Expanded indication would cover patients 12 years of age or younger, a population that comprises approximately ...
Posted by Michael Wonder on 12 Jun 2023
FDA approves first treatment for paediatric functional constipation
12 June 2023 - The FDA has approved Linzess (linaclotide) capsules to treat functional constipation in paediatric patients 6 to ...
Posted by Michael Wonder on 10 Jun 2023
Paediatric drug and other shortages in the age of supply chain disruption
9 June 2023 - The last year witnessed several significant shortages of key medicines and other products for children, including ...
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 ...