Blog
RSS FeedPosted 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 ...
Posted 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, ...