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RSS FeedPosted by Michael Wonder on 28 Nov 2016
Advanced Accelerator Applications reports feedback from the FDA for Lutathera, an investigational treatment for neuroendocrine tumours
28 November 2016 - Last week, the FDA issued feedback to the new drug application for Lutathera for the treatment ...
Posted by Michael Wonder on 28 Nov 2016
FDA grants priority review to Merck’s supplemental biologics license application seeking approval for Keytruda (pembrolizumab) for new indication in microsatellite instability-high cancer
28 November 2016 - Merck today announced that the U.S. FDA accepted for review the supplemental biologics license application for Keytruda ...
Posted by Michael Wonder on 27 Nov 2016
TherapeuticsMD announces FDA acceptance of new drug application and PDUFA date for Yuvvexy (TX-004HR)
19 September 2016 - PDUFA target action date of 7 May 2017. ...
Posted 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 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 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. ...
Posted by Michael Wonder on 01 Nov 2016
Novartis LEE011 (ribociclib) granted FDA priority review for first-line treatment of HR+/HER2- advanced breast cancer
1 November 2016 - A marketing authorization application for LEE011 plus letrozole has also been accepted for review by the ...