FDA

FDA issues draft guidance on medical devices, launching pilot program with nine companies

Monday, December 5, 2011 09:15 AM

The FDA has issued two draft guidance documents that focus on early-stage development of medical devices. 

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FDA issues draft guidance for artificial pancreas device systems

Friday, December 2, 2011 04:32 PM

The FDA has issued draft guidance designed to help investigators and manufacturers as they develop and seek approval for artificial pancreas device systems to treat type 1 diabetes.

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ADVENTRX meets with FDA to review ANX-188

Friday, December 2, 2011 04:23 PM

ADVENTRX Pharmaceuticals met with the FDA to review development plans for ANX-188 (purified poloxamer 188), the company's first-in-class treatment for sickle cell patients experiencing vaso-occlusive crisis.

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Nearly 90 medicines and vaccines in development for HIV/AIDS

Friday, December 2, 2011 03:51 PM

America’s biopharmaceutical research companies are testing 88 medicines and vaccines to treat or prevent HIV/AIDS and related conditions, according to a report by the Pharmaceutical Research and Manufacturers of America (PhRMA).

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FDA approves first generic version of Lipitor

Thursday, December 1, 2011 12:17 PM

The FDA has approved the first generic version of the cholesterol-lowering drug Lipitor.

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FDA accepts NDA for myeloma drug

Tuesday, November 29, 2011 11:34 AM

The FDA has accepted Onyx Pharmaceuticals' New Drug Application (NDA)
submission for carfilzomib, a next generation proteasome inhibitor, for the potential treatment of patients with relapsed and refractory multiple myeloma.

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FDA approves Intermezzo to treat insomnia

Monday, November 28, 2011 11:08 AM

The FDA has approved Intermezzo (zolpidem tartrate sublingual tablets) for use as needed to treat insomnia characterized by middle-of-the-night waking followed by difficulty returning to sleep.

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Gilead Sciences acquires Pharmasset, looks to duplicate its HIV success in hepatitis C

Monday, November 28, 2011 08:02 AM

Consolidation among drug sponsors continues. 

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Boston Scientific's PROMUS Element Stent receives FDA approval

Wednesday, November 23, 2011 10:31 AM

The FDA has approved Boston Scientific's PROMUS Element plus everolimus-eluting platinum chromium coronary stent system, the company's next-generation drug-eluting stent (DES) technology. The PROMUS Element Stent, designed to provide physicians improved DES performance in treating patients with coronary artery disease, is built on an innovative platinum chromium (PtCr) platform with
the market-leading everolimus drug.  The company plans to begin marketing
the product in the U.S. immediately.

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Tasly Pharmaceuticals selects ICON for phase III T89 trial

Monday, November 21, 2011 04:52 PM

ICON has been selected by Tasly Pharmaceuticals for the company’s global phase III T89 trial. T89, also known as Dantonic pill, aims to become the first traditional Chinese medicine to receive FDA approval in the United States. Dantonic pill is a botanical product for the treatment of chronic stable angina pectoris due to coronary heart disease. It is a modernized version of a traditional Chinese herbal medicine and was approved by the State Food and Drug Administration (SFDA) of China in 1993. Since then, more than 2 billion doses have been used by over 10 million patients. 

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