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RSS FeedPosted 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 ...
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 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 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 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 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 ...
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 ...