Blog
RSS FeedPosted by Michael Wonder on 15 May 2018
FDA approves subcutaneous formulation of Actemra for use in active polyarticular juvenile idiopathic arthritis, a rare form of juvenile arthritis
14 May 2018 - Genentech announced today that the U.S. FDA has approved the subcutaneous formulation of Actemra (tocilizumab) for the ...
Posted by Michael Wonder on 15 May 2018
UCB announces Briviact (brivaracetam) now approved by FDA to treat partial-onset (focal) seizures in paediatric epilepsy patients
14 May 2018 - Indication comes less than 2 years after the launch of Briviact in the U.S., building on existing ...
Posted by Michael Wonder on 12 May 2018
FDA expands approval of Gilenya to treat multiple sclerosis in paediatric patients
11 May 2018 - The U.S. Food and Drug Administration today approved Gilenya (fingolimod) to treat relapsing multiple sclerosis (MS) in ...
Posted by Michael Wonder on 03 May 2018
Cellectar receives rare paediatric disease designation for CLR 131 to treat neuroblastoma
2 May 2018 - Cellectar Biosciences announces today that the U.S. FDA has granted rare paediatric disease designation to the ...
Posted by Michael Wonder on 23 Apr 2018
Pfizer granted FDA breakthrough therapy designation for Trumenba (meningococcal Group B vaccine) for the prevention of invasive meningococcal B disease in children aged 1 to 9 years
23 April 2018 - Pfizer today announced that Trumenba (meningococcal Group B vaccine) received breakthrough therapy designation from the U.S. FDA ...
Posted by Michael Wonder on 03 Apr 2018
Eisai submits supplemental new drug application to FDA for Fycompa (perampanel) paediatric indications
31 March 2018 - First step to making Fycompa available for children, underscoring Eisai's commitment to epilepsy care for patients of ...
Posted by Michael Wonder on 22 Mar 2018
Novartis drug Tasigna approved by FDA to treat children with rare form of leukaemia
22 March 2018 - New indication approved under FDA Priority Review designation; provides clinicians with paediatric-specific safety and clinical data. ...
Posted by Michael Wonder on 16 Feb 2018
Shire announces FDA acceptance of application for Cinryze (C1 esterase inhibitor [human]) for paediatric hereditary angioedema use
15 February 2018 - If approved, Cinryze will be the first and only C1-INH therapy indicated to help prevent HAE attacks ...
Posted by Michael Wonder on 19 Jan 2018
Aquestive Therapeutics announces U.S. FDA filing acceptance of new drug application for clobazam oral soluble film to treat Lennox-Gastaut syndrome
18 January 2018 - Aquestive Therapeutics today announced that the U.S. FDA has accepted for review the company’s new drug application ...
Posted by Michael Wonder on 13 Jan 2018
GSK receives FDA approval for expanded indication for Fluarix Quadrivalent (influenza vaccine) for persons 6 months and older
11 January 2018 - GSK announced today it has received approval from the US FDA's Center for Biologics Evaluation and Research ...
Posted by Michael Wonder on 29 Dec 2017
GW Pharmaceuticals announces acceptance of NDA filing for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
28 December 2017 - GW Pharmaceuticals today announced that the U.S. FDA has accepted for filing with priority review its recently ...
Posted by Michael Wonder on 28 Dec 2017
Horizon Pharma announces FDA approval to expand the indication for Procysbi (cysteamine bitartrate) delayed-release capsules to include children one year of age and older living with nephropathic cystinosis
27 December 2017 - Horizon Pharma today announced the U.S. FDA has approved an expansion to the indication for Procysbi (cysteamine ...
Posted by Michael Wonder on 19 Dec 2017
Novartis multiple sclerosis therapy fingolimod granted FDA breakthrough therapy designation for paediatric multiple sclerosis
18 December 2017 - In a pivotal Phase III study, oral fingolimod significantly reduced relapses by 82% in a paediatric patient ...
Posted by Michael Wonder on 30 Nov 2017
Merck receives FDA approval for Isentress (raltegravir), in combination with other antiretroviral agents, for the treatment of HIV-1 infection in newborns weighing at least 2 kg
29 November 2017 - Only integrase inhibitor approved in the United States for treatment of HIV-1 in newborns from birth ...
Posted by Michael Wonder on 10 Nov 2017
U.S. FDA expands approval of Sprycel (dasatinib) to include treatment of children with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase
10 November 2017 - Approval based on data from the largest prospective trial in paediatric chronic myeloid leukaemia in chronic phase. ...