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Novartis drug Signifor® recommended by FDA advisory committee for approval to treat patients with Cushing’s disease
7 November 2012 | By Novartis
Committee votes unanimously in favor of Signifor (pasireotide)...
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Food and Drug Administration (FDA)
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U.S. Food and Drug Administration approves Pfizer’s XELJANZ® (tofacitinib citrate)
6 November 2012 | By Pfizer
The U.S. FDA has approved XELJANZ®...
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FDA discloses focus of Advisory Committee meeting on insulin degludec and insulin degludec/insulin aspart
25 October 2012 | By Novo Nordisk
“This meeting will focus on the cardiovascular safety of two products..."
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Biogen Idec receives notification of PDUFA date extension
18 October 2012 | By Biogen Idec
Biogen Idec announced that the U.S. FDA has extended the initial PDUFA date for its review...
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Biogen Idec receives notification of PDUFA date extension
17 October 2012 | By Biogen Idec
Biogen Idec announced that the U.S. FDA has extended the initial PDUFA date...
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FDA clears ACCU-CHEK Inform II
16 October 2012 | By Roche
Hospital point-of-care system for blood glucose testing with improved accuracy and wireless data transfer Next-generation system...
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FDA approves new indication for Prolia® (Denosumab) for the treatment of bone loss in men with osteoporosis at high risk for fracture
20 September 2012 | By Amgen
A new indication for Prolia® approved...
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Gerresheimer passes the inspection of all quality inspections
12 September 2012 | By Gerresheimer AG
Gerresheimer Medical Plastic Systems Dongguan Co. is an FDA-inspected medical device...
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FDA approves Genzyme’s AUBAGIO®
12 September 2012 | By Sanofi
AUBAGIO® (teriflunomide), a once-daily, oral treatment for relapsing Multiple Sclerosis...
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U.S. Food and Drug Administration approves BOSULIF® (bosutinib)
4 September 2012 | By Pfizer
“BOSULIF is the third new medicine to be approved by the FDA in just 13 months..."
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U.S. FDA approves Gilead’s Stribild™
27 August 2012 | By Gilead Sciences
Gilead Sciences, Inc. announced that the U.S. Food and Drug Administration (FDA) has approved StribildTM...
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U.S. Food And Drug Administration extends action date for tofacitinib new drug application by three months
21 August 2012 | By Pfizer
The U.S. FDA has extended the action date by three months for the NDA for tofacitinib...
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Sanofi announces FDA approval for Auvi-Q™
13 August 2012 | By Sanofi
Breakthrough device design talks patients and caregivers through the injection process...
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FDA approves Lucentis (ranibizumab injection) for treatment of diabetic macular edema
13 August 2012 | By Roche
First major treatment advance in more than 25 years for sight-threatening condition...
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Abbott’s Omnilink Elite® Vascular Balloon-Expandable Stent System receives FDA approval
7 August 2012 | By Abbott
The U.S. FDA has approved the Omnilink Elite® Vascular Balloon-Expandable Stent System...
