Blog
RSS FeedPosted 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 ...
Posted by Michael Wonder on 07 Jun 2018
FDA grants rare paediatric disease designation to Cellectar Biosciences’ CLR 131 for the treatment of rhabdomyosarcoma
6 June 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to CLR 131, ...
Posted by Michael Wonder on 31 May 2018
U.S. FDA designates for priority review Eisai's supplemental new drug application for anti-epiletic drug Fycompa as treatment for paediatric patients with epilepsy
31 May 2018 - Eisai has announced the U.S. FDA has accepted for review the supplemental new drug application for ...
Posted by Michael Wonder on 22 May 2018
GSK receives US approval of Arnuity Ellipta for use in children from 5 years old who suffer from asthma
21 May 2018 - GSK today announced it has received approval from the US FDA for the use of Arnuity Ellipta ...
Posted by Michael Wonder on 17 May 2018
Myonexus Therapeutics receives FDA rare paediatric drug designation for pioneering treatment of limb girdle muscular dystrophy Type 2E
16 May 2018 - Rare paediatric disease designation for MYO-101 program reflects compelling data and enables priority eeview voucher eligibility. ...
Posted by Michael Wonder on 17 May 2018
Castle Creek Pharmaceuticals receives FDA rare paediatric disease designation for diacerein 1% ointment for epidermolysis bullosa
16 May 2018 - Castle Creek Pharmaceuticals today announced that the U.S. FDA has granted rare paediatric disease designation for diacerein ...
Posted by Michael Wonder on 16 May 2018
U.S. FDA approves expanded indication for Truvada (emtricitabine and tenofovir disoproxil fumarate) for reducing the risk of acquiring HIV-1 in adolescents
15 May 2018 - First agent indicated for uninfected adolescents at risk of acquiring HIV. ...