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RSS FeedPosted 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. ...
Posted 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 ...