Blog
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 28 Nov 2016
Could the FDA be dismantled under Trump?
22 November 2016 - Has President-elect Donald Trump put a bull’s-eye on the FDA? ...
Posted by Michael Wonder on 28 Nov 2016
Republicans reach deal to pass Cures Act by end of year, but Democrats pushing for changes
27 November 2016 - House and Senate leaders announced late Friday night that they had finally hammered out a deal ...
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 27 Nov 2016
Drug makers find competition doesn’t keep a lid on prices
27 November 2016 - Makers of Viagra, Cialis show how rivals tend to raise prices in tandem, a reason for the ...
Posted by Michael Wonder on 26 Nov 2016
Many in Florida count on Obama’s health law, even amid talk of its demise
25 November 2016 - Dalia Carmeli, who drives a trolley in downtown Miami, voted for Donald J. Trump on Election ...
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 22 Nov 2016
Sanofi receives FDA approval of Soliqua 100/33, for the treatment of adults with type 2 diabetes
21 November 2016 - Sanofi announced today that the U.S. FDA approved once-daily Soliqua 100/33 (insulin glargine & lixisenatide injection) ...
Posted by Michael Wonder on 22 Nov 2016
High prices for some leukaemia drugs will make them less cost-effective
21 November 2016 - Pills used to treat a form of leukaemia may be more effective and convenient than chemotherapy, ...
Posted by Michael Wonder on 22 Nov 2016
Mallinckrodt will initiate company-sponsored clinical trial of H.P. Acthar Gel in treatment of amyotropic lateral sclerosis
21 November 2016 - Investigational new drug application for use of H.P Acthar Gel in amyotropic lateral sclerosis awarded fast ...
Posted by Michael Wonder on 22 Nov 2016
U.S. FDA grants fast track designation for the development of Oragenics’ AG013 for oral mucositis
21 November 2016 - Oragenics today announced that the U.S. FDA granted fast track designation to AG013, the Company’s lead ...