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Novartis drug Zortress® is first in over a decade approved by FDA to prevent organ rejection in adult liver transplant patients
15 February 2013 | By Novartis
The FDA has approved Zortress®...
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Food and Drug Administration (FDA)
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ViiV Healthcare announces FDA priority review designation for dolutegravir as a potential treatment for HIV infection
15 February 2013 | By GlaxoSmithKline
The FDA has granted a priority review designation to dolutegravir...
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Teva announces FDA approval of generic Adderall XR®
14 February 2013 | By Teva Pharmaceutical Industries Ltd
TEVA announced that the U.S. FDA has approved its Abbreviated New Drug Application (ANDA)...
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FDA Advisory Committee recommends approval of olodaterol* for maintenance treatment of COPD
29 January 2013 | By Boehringer Ingelheim
Olodaterol may provide a new treatment option in patients with COPD...
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Genzyme’s LEMTRADA™ application for MS accepted for review by the FDA
28 January 2013 | By Sanofi
Genzyme also reports very encouraging early launch indicators for AUBAGIO® (teriflunomide) in U.S.
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FDA approves new use of Avastin plus chemotherapy for people with metastatic colorectal cancer
24 January 2013 | By Roche
Roche announced that the US FDA approved a new use of Avastin...
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Biogen Idec and Elan submit applications for first-line use of TYSABRI in anti-JCV antibody negative patients with MS
16 January 2013 | By Biogen Idec
Biogen Idec and Elan have submitted applications to the U.S. FDA...
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Regulatory update – GSK announces submission of albiglutide BLA to the US FDA for the treatment of type 2 diabetes
14 January 2013 | By GlaxoSmithKline
Albiglutide is not yet approved as a treatment for type 2 diabetes...
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Abbott announces FDA approval and U.S. launch of next-generation XIENCE Xpedition™ drug eluting stent system
3 January 2013 | By Abbott
FDA approval - XIENCE Xpedition™ Everolimus Eluting Coronary Stent System...
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FDA grants accelerated approval for SIRTURO™ (bedaquiline)
31 December 2012 | By Johnson & Johnson
FDA has granted accelerated approval to SIRTURO™ Tablets for the treatment of pulmonary multi-drug resistant tuberculosis...
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Roche announces FDA approval of Tamiflu for the treatment of influenza in infants
22 December 2012 | By Roche
First medicine approved to treat influenza in infants two weeks of age and older...
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Novartis receives FDA approval for Flucelvax®, the first cell-culture vaccine in US to help protect against seasonal influenza
20 November 2012 | By Novartis
The US FDA approved the use of Flucelvax®...
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FDA approves new indication for PROMACTA® (eltrombopag)
19 November 2012 | By GlaxoSmithKline
GlaxoSmithKline plc announced that the U.S. FDA has approved PROMACTA for the treatment of thrombocytopenia...
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Vote from FDA advisory committee to recommend approval of H5N1 influenza vaccine candidate
14 November 2012 | By GlaxoSmithKline
“GSK has been collaborating with the U.S. Department of Health and Human Services..."
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Insulin degludec and insulin degludec/insulin aspart receive positive vote for approval
9 November 2012 | By Novo Nordisk
“The positive vote from the Advisory Committee marks an important step..."
