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Tag Archives: nda

Biodel Inc. (NASDAQ: BIOD) Gaining Traction with Investors as Clinical Studies Progress

Earlier this month shares of Biodel Inc. (NASDAQ: BIOD) were trading as low as 2.93 and attracting little in the way of volume but the specialty biopharmaceutical company focused on the development and commercialization of innovative treatments for diabetes that … Continue reading

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Has Aveo Pharmaceuticals, Inc. (NASDAQ: AVEO) Done Enough to Earn FDA Approval?

There are plenty of investors placing their bets on Aveo Pharmaceuticals, Inc. (NASDAQ: AVEO) as the cancer therapeutics company, doing business as Aveo Oncology, nears the date in which they will face the FDA’s Oncologic Drugs Advisory Committee (ODAC) for … Continue reading

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EnergySolutions, Inc. (NYSE: ES) Facing Uncertain Future in Nuclear Industry Despite Positive Earnings Report

It has been nearly two months since EnergySolutions, Inc. (NYSE: ES) went through a brutal three-day trading period in which their shares tumbled from a high of 3.64 to a low of 1.62 and while shares of the company, which … Continue reading

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Elite Pharmaceuticals, Inc. (OTCBB: ELTP) Continuing Development of Oral Controlled Release Product Formulations

It was a wild few days for Elite Pharmaceuticals, Inc. (OTCBB: ELTP) last week as shares of the specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations hit a six-month high of 0.1740 on Tuesday, fell … Continue reading

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Future of Alexza Pharmaceuticals (NASDAQ: ALXA) Could be Determined Over the Next Six Months as NDA Ready for Submission to FDA Once More

With the resubmission of their New Drug Application to the FDA for AZ-004 now pushed back to August 8, 2011 shares in Alexza Pharmaceuticals (NASDAQ: ALXA) have dipped slightly, trading around the 1.47 – 1.53 range, sliding below their 50-day … Continue reading

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Transcept Pharmaceuticals (NASDAQ: TSPT) Facing Difficult Task of Satisfying Lofty Demands of FDA for Approval of Intermezzo

Just what kind of shape Transcept Pharmaceuticals (NASDAQ: TSPT) is in remains unclear as the small biotech company looks for direction following a second rejection letter from the FDA concerning their insomnia drug Intermezzo. Despite the FDA’s acknowledgements that Intermezzo … Continue reading

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