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RSS FeedPosted by Michael Wonder on 27 Nov 2016
Neurocrine announces Ingrezza (valbenazine) new drug application for the treatment of tardive dyskinesia has been accepted for priority review by U.S. FDA
11 October 2016 - Neurocrine Biosciences today announced that the U.S. FDA has accepted for priority review the new drug application ...
Posted by Michael Wonder on 27 Nov 2016
Janssen submits application to EMA seeking approval of anti-interleukin 23 monoclonal antibody guselkumab for the treatment of moderate to severe plaque psoriasis
25 November 2016 - Janssen-Cilag announced today the submission of a marketing authorisation application to the EMA seeking approval of guselkumab ...
Posted by Michael Wonder on 26 Nov 2016
Emmaus’ new drug application for sickle cell disease accepted for review by FDA
8 November 2016 - Emmaus Life Sciences announced today that the FDA has accepted for review the new drug application ...
Posted by Michael Wonder on 26 Nov 2016
Arog Pharmaceuticals receives FDA fast track designation for crenolanib for advanced gastro-intestinal stromal tumours with a D842V mutation in the PDGFRA gene
16 November 2016 - Arog Pharmaceuticals, today announced that the U.S. FDA has granted fast track designation for crenolanib for the ...
Posted by Michael Wonder on 26 Nov 2016
Melinta Therapeutics submits Baxdela new drug application for hospital-treated skin infections
24 October 2016 - Melinta Therapeutics announced today that it has submitted new drug applications to the U.S. FDA for approval ...
Posted by Michael Wonder on 26 Nov 2016
GSK announces EU regulatory submission of candidate vaccine for prevention of shingles - follows regulatory submissions in US and Canada
25 November 2016 - GlaxoSmithKline today announced the regulatory submission of a marketing authorisation application to the EMA seeking approval ...
Posted by Michael Wonder on 25 Nov 2016
CADTH calls for input on submission for new medicine for patients with biliary cirrhosis
24 November 2016 - CADTH is calling for patient input on a pending submission from Intercept Pharmaceuticals for obeticholic acid. ...
Posted by Michael Wonder on 24 Nov 2016
Updated submission form and guide for Patient Group Partners
24 November 2016 - Following feedback from patient groups and our committee members, the SMC has introduced an updated Patient ...
Posted by Michael Wonder on 21 Nov 2016
Intarcia submits new drug application to FDA for U.S. marketing approval of ITCA 650 in type 2 diabetes
21 November 2016 - ITCA 650 is the first investigational drug to use Intarcia’s disruptive Medici Drug Delivery System to ...
Posted by Michael Wonder on 21 Nov 2016
GSK files regulatory submission in US for once-daily closed triple combination therapy FF/UMEC/VI for patients with COPD
21 November 2016 - GSK and Innoviva today announced the filing by GSK of a regulatory submission with the US ...
Posted by Michael Wonder on 17 Nov 2016
Centrexion Therapeutics announces fast track designation granted by FDA to CNTX-4975 for treatment of Morton’s neuroma
15 November 2016 - CNTX-4975 has potential to be the first non-surgical FDA-approved treatment for orphan disease, painful foot nerve ...
Posted by Michael Wonder on 16 Nov 2016
Amgen and Allergan submit biosimilar biologics license application for ABP 215 to U.S. FDA
15 November 2016 - Supported by phase 3 study in patients with non-squamous non-small-cell lung cancer. ...
Posted by Michael Wonder on 16 Nov 2016
ARMO BioSciences’ immunotherapy AM0010 receives orphan drug and fast track designations from the U.S. FDA for the treatment of pancreatic cancer
14 November 2016 - ARMO BioSciences announced that the U.S. FDA has granted the Company’s lead investigational immuno-oncology drug AM0010 ...
Posted by Michael Wonder on 15 Nov 2016
Eagle Pharmaceuticals initiates rolling submission of NDA for Ryanodex in exertional heat stroke
11 November 2016 - Eagle Pharmaceuticals today announced that the Company has initiated the rolling submission of its new drug application ...
Posted by Michael Wonder on 03 Nov 2016
Tesaro announces submission of niraparib new drug application for platinum-sensitive, recurrent ovarian cancer
1 November 2016 - Teasro today announced that it has completed the niraparib rolling new drug application submission to the U.S. ...