Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 14 Sep 2018
FDA approves subcutaneous formulation of Actemra for use in active systemic juvenile idiopathic arthritis, a rare form of juvenile arthritis
13 September 2018 - Genentech announced today that the U.S. FDA has approved the subcutaneous formulation of Actemra (tocilizumab) for the ...
Posted by Michael Wonder on 12 Sep 2018
FDA awards five grants to advance the development of paediatric medical devices
12 September 2018 - The U.S. FDA announced today that it has awarded five grants totalling up to $6 million per ...
Posted by Michael Wonder on 30 Aug 2018
U.S. Food and Drug Administration accepts Bristol-Myers Squibb’s application for Sprycel (dasatinib) in paediatric patients with newly diagnosed Philadelphia chromosome positive acute lymphoblastic leukaemia
30 August 2018 - Application based on results from Phase 2 CA180-372 study. ...
Posted by Michael Wonder on 21 Aug 2018
FDA analysis shows similar success rates for paediatric trials using clinical and surrogate outcomes
21 August 2018 - An analysis by US FDA officials published earlier this month finds that there is a similar ...
Posted by Michael Wonder on 26 Jul 2018
Drug companies can’t game paediatric drug laws anymore
26 July 2018 - Drug companies can’t avoid including kids in certain clinical studies now that the FDA has finally ...