Blog
RSS FeedPosted by Michael Wonder on 17 Sep 2017
Sunovion’s Aptiom (eslicarbazepine acetate) receives FDA approval for expanded indication to treat partial-onset seizures in children and adolescents 4 years of age and older
14 September 2017 - Aptiom provides an important new treatment option for children and adolescents four to 17 years of age ...
Posted by Michael Wonder on 29 Jul 2017
U.S. FDA grants priority review for an epinephrine auto-injector in development by Kaléo specifically for infants and small children
27 July 2017 - AUVI-Q (epinephrine injection) 0.1 mg could be the first auto-injector approved with a needle length and dose ...
Posted by Michael Wonder on 25 Jul 2017
GSK submits US regulatory filing of Arnuity Ellipta in children with asthma
24 July 2017 - GSK today announced the filing of a supplementary new drug application to the US FDA for the ...
Posted by Michael Wonder on 24 Jul 2017
U.S. FDA expands approval of Yervoy (ipilimumab) to include paediatric patients 12 years and older with unresectable or metastatic melanoma
24 July 2017 - First Bristol-Myers Squibb immuno-oncology approval for adolescents 12 years and older reflects the company’s commitment to the ...
Posted by Michael Wonder on 19 Jul 2017
Capricor receives rare paediatric disease designation from FDA for CAP-1002 for patients with Duchenne muscular dystrophy
18 July 2017 - Designation covers broad treatment of Duchenne muscular dystrophy. ...
Posted by Michael Wonder on 12 Jul 2017
FDA grants full approval for Blincyto (blinatumomab) to treat relapsed or refractory B-cell precursor acute lymphoblastic leukaemia in adults and children
11 July 2017 - Data from the phase 3 TOWER study support conversion from accelerated to full approval. ...
Posted by Michael Wonder on 21 Jun 2017
U.S. FDA approves Mydayis (mixed salts of a single-entity amphetamine product) – a new once daily option for ADHD symptom control in patients 13 years and older
20 June 2017 - Mydayis demonstrated improvements lasting up to 16 hours post-dose, beginning at 2 or 4 hours post-administration, ...
Posted by Michael Wonder on 21 Jun 2017
Neos Therapeutics announces FDA approval of Cotempla XR-ODT (methylphenidate) extended release orally disintegrating tablets for the treatment of ADHD in patients 6 to 17 years old
19 June 2017 - First approved methylphenidate extended release orally disintegrating tablet for the treatment of ADHD. ...
Posted by Michael Wonder on 18 Jun 2017
Fibrocell receives rare paediatric disease designation from FDA for FCX-013 for treatment of localised scleroderma
12 June 2017 - Gene therapy candidate under control of RheoSwitch therapeutic system technology is potential first-in-class treatment for chronic ...
Posted by Michael Wonder on 08 Jun 2017
Burtomab receives breakthrough therapy designation for advanced form of paediatric cancer
7 June 2017 - Burtomab, a drug for metastatic neuroblastoma, has been granted breakthrough therapy designation by the FDA for the ...
Posted by Michael Wonder on 06 Jun 2017
Workshop: addressing unmet needs of children with pulmonary arterial hypertension
6 June 2017 - The EMA, the United States FDA and Health Canada are co-organising a workshop to discuss the ...
Posted by Michael Wonder on 02 May 2017
Horizon Pharma announces FDA approval to expand the age range for Ravicti (glycerol phenylbutyrate) oral liquid to people with urea cycle disorders two months of age and older
1 May 2017 - Horizon Pharma today announced the U.S. FDA has approved its supplemental new drug application to expand the ...
Posted by Michael Wonder on 07 Apr 2017
FDA approves two hepatitis C drugs for paediatric patients
7 April 2017 - The U.S. FDA today approved supplemental applications for Sovaldi (sofosbuvir) and Harvoni (ledipasvir and sofosbuvir) to ...
Posted by Michael Wonder on 16 Mar 2017
Sunovion submits supplemental new drug application to FDA for use of Aptiom (eslicarbazepine acetate) for the treatment of partial-onset seizures in children 4 years of age and older
15 March 2017 - If approved, Aptiom would provide an important new monotherapy or adjunctive therapy treatment option for individuals ...
Posted by Michael Wonder on 16 Mar 2017
GSK announces US regulatory submission seeking expanded indication for Fluarix Quadrivalent (influenza vaccine) for infants 6 months and older
15 March 2017 - GSK today announced the submission of a supplemental biologics license application to the U.S. FDA for ...