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BYETTA® approved for use with insulin glargine in the U.S.
19 October 2011 | By Eli Lilly and Company
FDA has approved a new use for BYETTA® (exenatide) injection....
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Cialis® for once daily use now FDA approved
7 October 2011 | By Eli Lilly and Company
Eli Lilly and Company (NYSE: LLY) announced today that the U.S. Food and Drug Administration (FDA) has approved Cialis® (tadalafil) tablets for once daily use for the treatment of men who have both erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia (ED+BPH). The FDA also approved Cialis…
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FDA approves Merck’s JUVISYNC™ (sitagliptin and simvastatin) tablets
7 October 2011 | By Merck
Multiple national guidelines recommend that patients with type 2 diabetes be treated for cholesterol...
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FDA accepts New Drug Application filing for ridaforolimus, investigational mTOR inhibitor
5 October 2011 | By Merck
The FDA accepted for filing and review the New Drug Application for ridaforolimus...
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Amgen announces PDUFA date for XGEVA® supplemental Biologics License Application
22 August 2011 | By Amgen
The FDA will target a PDUFA action date of April 26, 2012 for the sBLA...
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FDA Clears Abbott’s Genetic FISH Panel for Leukemia Patient Prognosis
22 August 2011 | By
Abbott has received 510k clearance from the FDA...
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FDA approves Zelboraf (vemurafenib)
17 August 2011 | By Roche
First and only personalized medicine shown to help people with BRAF V600E mutation-positive metastatic melanoma...
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FDA approve two three-month strengths of Lupron Depot-PED® (leuprolide acetate for depot suspension)
16 August 2011 | By Abbott
Two strengths for three-month administration of Lupron Depot-PED ® approved...
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Abbott receives U.S. FDA approval for RX Herculink Elite® Renal Stent System
10 August 2011 | By Abbott
The U.S. FDA approved the RX Herculink Elite® Renal Stent System for the treatment of renal artery stenosis...
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U.S. FDA approves Gilead Sciences’ Complera™
10 August 2011 | By Gilead Sciences Inc
A new complete once-daily, single-tablet regimen for HIV-1 infection in treatment-naïve adults...
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Regulatory update: GSK and XenoPort submit supplemental new drug application to FDA
9 August 2011 | By GlaxoSmithKline
GSK and XenoPort, Inc. request approval of Horizant™...
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U.S. FDA approves subcutaneous formulation of ORENCIA® (abatacept)
29 July 2011 | By Bristol-Myers Squibb
ORENCIA® (abatacept) treatment for adults with moderate to severe rheumatoid arthritis (RA)...
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Pfizer provides U.S. regulatory update on Prevnar 13®
29 July 2011 | By Pfizer
The U.S. FDA issued a 90-day extension to the action date for the Company’s sBLA for use of Prevnar 13®...
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Viramune® (nevirapine) receives CHMP recommendation for approval
27 July 2011 | By Boehringer Ingelheim
The CHMP issued a Positive Opinion recommending the approval of Viramune® (nevirapine)...
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Cephalon receives FDA approval for Risk Evaluation and Mitigation Strategy for FENTORA and ACTIQ
21 July 2011 | By Cephalon, Inc.
The FDA approved the Risk Evaluation and Mitigation Strategy for FENTORA® & ACTIQ®...
