Drug Approvals

FDA Approves ACIPHEX Sprinkle for Use in Children

The Eisai capsules have been approved for treatment of GERD in children ages one to 11.

Eisai Inc. announced today that the U.S. Food and Drug Administration (FDA) has approved ACIPHEX Sprinkle Delayed-Release Capsules 5mg and 10mg for the treatment of Gastroesophageal Reflux Disease (GERD) in children 1 to 11 years of age for up to 12 weeks.  

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Report: FDA Approved 30 Percent More Drugs in 2012 Than the Previous Year

According to a recent market study, the agency’s drug approvals reached a 15-year high last year.

A sharp increase in drug approvals and mergers and acquisitions combined to create a bull market for the Biotechnology Industry in 2012. The iShares NASDAQ Biotechnology Index (IBB), the SPDR S&P Biotech ETF (XBI) and the First Trust Amex Biotechnology Index ETF (FBT) have all gained over 20 percent in the past year, outperforming the broader markets by a good margin. Research Driven Investing examines investing opportunities in the Biotech Industry and provides equity research on Amgen, Inc. (NASDAQ: AMGN) and Gilead Sciences, Inc. (NASDAQ: GILD).

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FDA Drug Approvals in 2012 Highest in 16 Years

The agency approved 39 new drugs last year, the highest level since 1996.

The U.S. Food and Drug Administration approved eight new drugs in December pushing the year's total to 39, its highest level since 1996 when the agency cleared a backlog of applications. 

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