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RSS FeedPosted 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. ...
Posted by Michael Wonder on 07 Nov 2017
UCB’s Vimpat (lacosamide) now approved by FDA to treat partial-onset seizures in paediatric epilepsy patients
6 November 2017 - Approval builds on existing adult monotherapy and adjunctive therapy indications, broadening clinical application for Vimpat tablets and ...
Posted by Michael Wonder on 02 Nov 2017
FDA grants rare paediatric disease designation to ArQule's miransertib (ARQ 092) for the treatment of Proteus syndrome
1 November 2017 - ArQule today announced that the U.S. FDA has granted rare paediatric disease designation to miransertib (ARQ ...
Posted by Michael Wonder on 01 Nov 2017
GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S. Food and Drug Administration for Epidiolex (cannabidiol) in the treatment of Lennox-Gastaut syndrome and Dravet syndrome
30 October 2017 - GW Pharmaceuticals today announced it has completed the rolling submission of a new drug application to ...
Posted by Michael Wonder on 29 Oct 2017
Atara Biotherapeutics receives rare paediatric disease designation from FDA for ATA230 for treatment of congenital cytomegalovirus infection
26 October 2017 - Atara Biotherapeutics today announced that ATA230 was granted rare paediatric disease designation for the treatment of ...
Posted by Michael Wonder on 14 Oct 2017
Janssen announces U.S. FDA approval of Stelara (ustekinumab) for the treatment of adolescents with moderate-to-severe plaque psoriasis
13 October 2017 - Findings from a registrational study showed Stelara led to significant skin clearance results at week 12. ...
Posted by Michael Wonder on 03 Oct 2017
Sucampo Pharmaceuticals announces FDA acceptance of sNDA for Amitiza in children with paediatric functional constipation, with priority review designation
28 September 2017 - Sucampo Pharmaceuticals today announced that the U.S. FDA has accepted for filing its recently submitted supplemental ...
Posted by Michael Wonder on 28 Sep 2017
Audentes Therapeutics announces rare paediatric disease and fast track designations for AT132 for the treatment of X-linked myotubular myopathy
27 September 2017 - Preliminary data from ASPIRO, the Phase 1 / 2 study of AT132, expected to be available in ...
Posted by Michael Wonder on 25 Sep 2017
BioCryst's Rapivab (peramivir injection) receives FDA approval for a paediatric indication
21 September 2017 - BioCryst Pharmaceuticals announced today that the U.S. FDA has approved a supplemental new drug application for ...