Blog
RSS FeedPosted by Michael Wonder on 06 Jan 2020
FDA approves Fiasp for treatment of children with diabetes
6 January 2020 - Novo Nordisk today announced that the U.S. FDA has approved Fiasp (insulin aspart injection) 100 u/mL for ...
Posted by Michael Wonder on 18 Dec 2019
Chondrial Therapeutics announces dosing of first patients in Phase 1 clinical program of CTI-1601 for treatment of Friedreich’s ataxia; CTI-1601 granted rare pediatric disease designation and fast track designation by U.S. FDA
18 December 2019 - Chondrial Therapeutics, a clinical-stage biotechnology company focused on developing treatments for rare diseases, with an initial ...
Posted by Michael Wonder on 13 Dec 2019
Y-mAbs’ GD2-GD3 vaccine granted rare paediatric disease designation
12 December 2019 - Y-mAbs Therapeutics today announced that its GD2-GD3 vaccine has been granted a rare paediatric disease designation ...
Posted by Michael Wonder on 12 Dec 2019
FDA issues draft guidance to foster oncology product development for paediatric populations
12 December 2019 - Today, the U.S. FDA issued a draft guidance document, “FDARA Implementation Guidance for Pediatric Studies of ...
Posted by Michael Wonder on 02 Dec 2019
Diurnal files adrenal insufficiency drug Alkindi in US
2 December 2019 - Could become only treatment for children with the condition. ...
Posted by Michael Wonder on 20 Nov 2019
Newron receives FDA rare paediatric disease designation for sarizotan for the treatment of Rett syndrome
19 November 2019 - Newron announced today that the U.S. FDA has granted the rare paediatric disease designation for sarizotan, ...
Posted by Michael Wonder on 14 Nov 2019
Anavex Life Sciences receives rare paediatric disease designation from FDA for Anavex 2-73 (blarcamesine) for the treatment of Rett syndrome
14 November 2019 - Anavex Life Sciences today announced that it received the rare paediatric disease designation from the U.S. FDA ...
Posted by Michael Wonder on 24 Oct 2019
FDA approves Botox (onabotulinumtoxinA) for paediatric patients with lower limb spasticity, excluding spasticity caused by cerebral palsy
24 October 2019 - Approval marks 11th Botox therapeutic indication and comes 30 years after the first indications were approved. ...
Posted by Michael Wonder on 16 Oct 2019
ProQR receives rare paediatric disease designation from FDA for sepofarsen for the treatment of LCA10
15 October 2019 - ProQR Therapeutics today announced that it received rare paediatric disease designation from the U.S. FDA for ...
Posted by Michael Wonder on 15 Oct 2019
Faced with a drug shortfall, doctors scramble to treat children with cancer
14 October 2019 - A critical chemotherapy medication is in short supply, and physicians say there is no appropriate substitute. ...
Posted by Michael Wonder on 07 Oct 2019
Janssen submits application to U.S. FDA seeking approval of Stelera (ustekinumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis
7 October 2019 - The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental biologics license ...
Posted by Michael Wonder on 03 Oct 2019
Novartis Entresto receives FDA approval for paediatric heart failure, helping to address critical unmet need for treatment options
1 October 2019 - Entresto is now approved for the treatment of paediatric patients aged 1 year and older with symptomatic ...
Posted by Michael Wonder on 27 Sep 2019
FDA approves first treatment for children with rare diseases that cause inflammation of small blood vessels
27 September 2019 - The U.S. FDA today approved Rituxan (rituximab) injection to treat granulomatosis with polyangiitis (GPA) and microscopic polyangiitis ...
Posted by Michael Wonder on 12 Sep 2019
Nucala is the first biologic approved in the US for six to 11-year-old children with severe eosinophilic asthma
12 September 2019 - GlaxoSmithKline today announced that the US FDA has approved Nucala (mepolizumab) for use in children as young ...
Posted by Michael Wonder on 04 Sep 2019
GeneTx and Ultragenyx announce orphan drug designation and rare paediatric disease designation for GTX-102
3 September 2019 - GeneTx Biotherapeutics and Ultragenyx today announced that the U.S. FDA has granted orphan drug designation and rare ...