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FDA Advisory Committee recommends approval of Remicade®
21 July 2011 | By
The Gastrointestinal Drugs Advisory Committee (GIDAC) of the U.S. FDA recommended the approval of REMICADE® (infliximab)...
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FDA approves new medicine BRILINTA (ticagrelor) for use in the US
20 July 2011 | By AstraZeneca
The US FDA has approved BRILINTA (ticagrelor) tablets...
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FDA Advisory Committee makes recommendation on investigational compound dapagliflozin
20 July 2011 | By AstraZeneca
FDA Endocrinologic and Metabolic Drugs Advisory Committee meeting outcome...
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Idera Reports Clinical Hold on Proposed Phase 2 Clinical Trial of IMO-3100
20 July 2011 | By Idera Pharmaceuticals
Idera Pharmaceuticals announced the receipt of a verbal communication from the U.S. FDA that a proposed Phase 2 protocol...
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Millennium submits supplemental new drug application with FDA
19 July 2011 | By Takeda Pharmaceutical Company Limited
Millennium announced the submission of a supplemental New Drug Application (sNDA) with the U.S. FDA for VELCADE® (bortezomib)...
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Pfizer affirms CHANTIX/CHAMPIX as important treatment option for smokers wanting to quit
4 July 2011 | By Pfizer
An effective and appropriate treatment option for adult smokers wanting to quit...
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Novartis receives FDA approval for Arcapta(TM) Neohaler(TM)
1 July 2011 | By Novartis
Novartis announced that the US FDA approved once-daily Arcapta(TM) Neohaler(TM) (indacaterol inhalation powder)...
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Pfizer files with the FDA for review of Axitinib for patients with advanced RCC
28 June 2011 | By Pfizer
The U.S. FDA has accepted Pfizer’s filing for standard review of axitinib for patients with advanced RCC...
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Amgen submits application to expand indication for XGEVA® (Denosumab)
27 June 2011 | By Amgen
Amgen announced the submission of a supplemental Biologics License Application to the U.S. FDA to expand the indication for XGEVA® (denosumab)...
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FDA Complete Response Letter received for REMOXY
24 June 2011 | By Pfizer
Pfizer & Pain Therapeutics, Inc. received a Complete Response Letter from the U.S. FDA...
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FDA panel endorses efficacy but not safety of Novartis drug ACZ885 for gouty arthritis
21 June 2011 | By Novartis
FDA panel voted in favor of the overall efficacy but not the overall safety of ACZ885...
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Abbott receives FDA approval for a new six-month formulation of Lupron Depot®
20 June 2011 | By Abbott
"Lupron Depot is an important treatment option for many patients..."
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Novartis application for expanded Menveo® indication from 2 months of age accepted for review by FDA
16 June 2011 | By Novartis
The US FDA has accepted for review its supplemental Biologics License Application...
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FDA approves NULOJIX® (belatacept)
16 June 2011 | By Bristol-Myers Squibb Company
Bristol-Myers Squibb Company (NYSE: BMY) announced that the U.S. Food and Drug Administration (FDA) approved NULOJIX, the first selective T-cell costimulation blocker indicated for the prophylaxis of organ rejection in adult patients receiving a kidney transplant, in combination with basiliximab induction, mycophenolate mofetil (MMF), and corticosteroids.
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Abbott receives FDA approval for CREON® (pancrelipase) infant-specific dosage
14 June 2011 | By Abbott
The U.S. FDA approved an infant-specific dose of CREON® (pancrelipase) Delayed-Release Capsules to treat EPI due to cystic fibrosis...
