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Luitpold Pharmaceuticals, Inc. receives complete response letter for Injectafer® from the U.S. FDA
26 July 2012 | By Daiichi Sankyo
Luitpold Pharmaceuticals submitted a New Drug Application to the U.S. FDA...
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Food and Drug Administration (FDA)
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Novartis gains FDA approval for Afinitor® in advanced breast cancer marking a significant milestone for women battling this disease
20 July 2012 | By Novartis
The US FDA has approved Afinitor® tablets...
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Meeting scheduled for insulin degludec and insulin degludec/insulin aspart
18 July 2012 | By Novo Nordisk
Meeting scheduled to discuss the NDA for the ultra-long-acting insulin degludec & insulin degludec/insulin aspart....
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U.S. FDA approves Gilead ’s Truvada® for reducing the risk of acquiring HIV
16 July 2012 | By Gilead Sciences
The U.S. FDA has approved once-daily oral Truvada®...
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US Regulatory Update – Tykerb® (lapatinib)
12 July 2012 | By GlaxoSmithKline
GlaxoSmithKline has withdrawn a supplemental New Drug Application to the US FDA for Tykerb...
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Abbott receives FDA approval for Healon EndoCoat protective gel for cataract surgery
3 July 2012 | By Abbott
Abbott has expanded its Healon® family of ophthalmic viscosurgical devices (OVDs)...
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Gilead submits New Drug Application to U.S. FDA for boosting agent cobicistat
28 June 2012 | By Gilead Sciences
Gilead Sciences has submitted a New Drug Application to the U.S. FDA for marketing approval of cobicistat...
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Gilead submits NDA to U.S. FDA for HIV integrase inhibitor elvitegravir for treatment-experienced patients
27 June 2012 | By Gilead Sciences Inc
Elvitegravir is also a component of Quad single tablet regimen...
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FDA issues complete response letter for Pfizer’s tafamidis meglumine New Drug Application
18 June 2012 | By Pfizer
Tafamidis is a novel, investigational medication for the treatment of TTR-FAP...
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U.S. District Court rules against Merck in NASONEX® (mometasone furoate monohydrate) patent lawsuit
15 June 2012 | By Merck
"While we are pleased with the court's ruling that the patent for NASONEX is valid..."
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GSK receives FDA approval for MenHibrix
14 June 2012 | By GlaxoSmithKline
First combination vaccine to help prevent meningococcal serogroups C and Y and Hib disease...
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Genzyme submits applications to FDA and EMA for approval of LEMTRADA™ (alemtuzumab) for multiple sclerosis
12 June 2012 | By Sanofi
Genzyme is developing LEMTRADA in MS in collaboration with Bayer HealthCare...
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FDA approves Perjeta (pertuzumab) for people with HER2-positive metastatic breast cancer
11 June 2012 | By Roche
Roche announced that the U.S. FDA has approved PerjetaTM (pertuzumab)...
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FDA extends regulatory review period for insulin degludec and insulin degludec/insulin aspart by three months
8 June 2012 | By Novo Nordisk
Regulatory review period extended for insulins degludec & insulin degludec/insulin aspart...
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GSK and XenoPort receive FDA approval for Horizant® for postherpetic neuralgia
7 June 2012 | By GlaxoSmithKline
The US FDA has approved Horizant® (gabapentin enacarbil)...
