Blog
RSS FeedPosted by Michael Wonder on 08 Mar 2019
FDA accepts supplemental biologics license applications for Botox (onabotulinumtoxinA) for paediatric patients with upper and lower limb spasticity
7 March 2019 - Applications seek to extend use of Botox for patients 2 to 17 years old. ...
Posted by Michael Wonder on 06 Mar 2019
FDA grants rare paediatric disease designation to odiparcil for the treatment of MPS VI
5 March 2019 - Inventiva eligible to receive priority review voucher upon approval of odiparcil for the treatment of MPS VI. ...
Posted by Michael Wonder on 11 Feb 2019
Clementia granted rare paediatric disease designation by FDA for palovarotene for fibrodysplasia ossificans progressiva
11 February 2019 - Clementia Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation to palovarotene for ...
Posted by Michael Wonder on 11 Feb 2019
RegenxBio receives rare paediatric disease designation for RGX-181 gene therapy for the treatment of CLN2 form of Batten disease
31 January 2019 - Novel, one-time investigational treatment for CLN2 disease designed to halt progression of this rare, paediatric, neurodegenerative disease. ...
Posted 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 ...