Blog
RSS FeedPosted by Michael Wonder on 01 May 2019
FDA approves Kalydeco (ivacaftor) as first and only CFTR modulator to treat eligible infants with CF as early as six months of age
30 April 2019 - Safety data from Phase 3 ARRIVAL study support treatment with Kalydeco in children ages six to <12 ...
Posted by Michael Wonder on 01 May 2019
FDA approves first treatment for all genotypes of hepatitis C in paediatric patients
30 April 2019 - The U.S. FDA today approved Mavyret (glecaprevir and pibrentasvir) tablets to treat all six genotypes of ...
Posted by Michael Wonder on 27 Apr 2019
FDA approves first treatment for paediatric patients with lupus
26 April 2019 - The U.S. FDA today approved Benlysta (belimumab) intravenous infusion for treatment of children with systemic lupus erythematosus ...
Posted by Michael Wonder on 19 Mar 2019
FDA implements new policies to advance the development of drugs to treat or prevent HIV, including in paediatric patients, as part of efforts to end HIV infection
19 March 2019 - The U.S. FDA today issued two final guidances for industry to help product sponsors understand the ...
Posted by Michael Wonder on 18 Mar 2019
Allergan announces FDA approval of Avycaz (ceftazidime and avibactam) for paediatric patients
18 March 2019 - Label now includes new data on use of Avycaz for treatment of cUTI and cIAI in paediatric ...
Posted by Michael Wonder on 12 Mar 2019
FDA approves Dupixent (dupilumab) for moderate-to-severe atopic dermatitis in adolescents
11 March 2019 - Only therapy that targets the IL-4/IL-13 pathway, a key driver of the allergic or type 2 inflammation ...
Posted 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. ...