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RSS FeedPosted by Michael Wonder on 24 Jan 2019
FDA approves use of 0.5 mL dose of Fluzone Quadrivalent (influenza vaccine) in children as young as 6 months of age
23 January 2019 - The 0.5 mL dose is now approved for use in children 6 months through 35 months of ...
Posted by Michael Wonder on 02 Jan 2019
Bristol-Myers Squibb’s Sprycel (dasatinib) tablets now approved in combination with chemotherapy in certain paediatric patients with Philadelphia chromosome-positive acute lymphoblastic leukemia
2 January 2018 - Approval marks second paediatric leukaemia indication for Sprycel. ...
Posted by Michael Wonder on 28 Dec 2018
Horizon Pharma announces FDA approval to expand the age range for Ravicti (glycerol phenylbutyrate) oral liquid to include newborns
27 December 2018 - Horizon Pharma today announced the U.S. FDA has approved a supplemental new drug application to expand the ...
Posted by Michael Wonder on 27 Dec 2018
FDA approves Vaxelis, Sanofi and MSD’s paediatric hexavalent combination vaccine
26 December 2018 - The U.S. FDA has approved Vaxelis (diphtheria and tetanus toxoids and acellular pertussis adsorbed, inactivated poliovirus, ...
Posted by Michael Wonder on 15 Dec 2018
FDA approves Nplate (romiplostim) for use in paediatric patients with immune thrombocytopenia
14 December 2018 - Application granted priority review designation. ...
Posted by Michael Wonder on 21 Nov 2018
ImmunoMolecular Therapeutics awarded SBIR grant and receives rare paediatric disease designation from FDA for IMT-002
14 November 2018 - Rare paediatric disease designation granted to IMT-002 for type 1 diabetes. ...
Posted by Michael Wonder on 21 Nov 2018
GSK submits US regulatory filing to expand the use of Nucala in children with severe eosinophilic asthma
19 November 2018 - GSK today announced the filing of a supplemental biologics license application to the US FDA seeking ...
Posted by Michael Wonder on 15 Nov 2018
Stallergenes Greer announces U.S. FDA approval of paediatric indication extension for Oralair sublingual immunotherapy tablet for the treatment of grass pollen allergy
14 November 2018 - Stallergenes Greer today announced that it has received approval from the U.S. FDA for the extension of ...
Posted by Michael Wonder on 14 Nov 2018
U.S. FDA accepts for filing Shire’s supplemental new drug application for Gattex (teduglutide [rDNA origin]) for children with short bowel syndrome
13 November 2018 - Seeking approval for the potential use of Gattex to paediatric patients builds on Shire’s decade-long commitment ...
Posted by Michael Wonder on 07 Nov 2018
FDA grants priority review for Dupixent (dupilumab) as potential treatment for adolescents with uncontrolled moderate to severe atopic dermatitis
6 November 2018 - Regeneron Pharmaceuticals and Sanofi today announced that the U.S. FDA has accepted for priority review the ...
Posted by Michael Wonder on 29 Oct 2018
Jazz Pharmaceuticals announces FDA approval of Xyrem (sodium oxybate) for the treatment of cataplexy or excessive daytime sleepiness in paediatric narcolepsy patients
29 October 2018 - This approval of Xyrem by the FDA marks the first medicine approved to treat cataplexy or excessive ...
Posted by Michael Wonder on 22 Oct 2018
Eiger BioPharmaceuticals receives FDA rare paediatric disease designation for lonafarnib for the treatment of progeria and progeroid laminopathies and plans NDA filing in 2019
22 October 2018 - Designation enables priority review voucher eligibility upon NDA approval. ...
Posted by Michael Wonder on 02 Oct 2018
FDA grants rare paediatric disease designation to pegzilarginase for arginase 1 deficiency
1 October 2018 - Aeglea eligible to receive a priority review voucher. ...
Posted by Michael Wonder on 01 Oct 2018
Fycompa newly approved by U.S. FDA as treatment for partial-onset seizures in paediatric patients with epilepsy
1 October 2018 - Eisai announced today that its U.S. subsidiary has received approval from the U.S. FDA for an ...
Posted by Michael Wonder on 17 Sep 2018
FDA grants rare paediatric disease designation to Cellectar Biosciences’ CLR 131 for the treatment of osteosarcoma
17 September 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to CLR 131 ...