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SPPI
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SPPI- a commercial-stage biotechnology company with a primary focus in oncology. Expecting some FDA approval news October 8th that should send this stock flying!
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SPPI - Eoquin FDA Fast Track Status
SPPI
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Today, the FDA notified SPPI that Eoquin, their drug candidate intended to treat non-muscle invasive bladder cancer, was granted fast tract status. SPPI expects to finish late-stage clinical trials by year end and to report the results two years later. <> SPPI is awaiting FDA decision set for Sept 7, 2009 for its experimental drug, Zevalin. In July, the FDA had asked for more data on it's application of an additional use of Zevalin to treat non-Hodgkin's lymphoma (NHL). Zevalin is already approved as a treament for patients with relapsed or refractory, low-grade or foilicular ><>>...
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BioMedReports FDA Calendar: Swine Flu Trial Set to Begin
SPPI
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<> Below is a summary of updates to the BioMedReports.com FDA Calendar , which includes a database of 265 entries as of 7/21/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com <> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage clinica>>...
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FDA Calendar Updates: DDSS, HGSI, OREX, SPPI, TRIB
SPPI
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<> Below is a summary of updates to the <font> BioMedReports.com FDA Calendar </font> , which includes a database of 263 entries as of 7/20/09. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of <font> BioMedReports.com </font> , the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pendin>...
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Spectrum Pharmaceuticals (Nasdaq: SPPI): Betsy de Parry’s Story, A Must-See Video, and More
SPPI
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Investors should find the resources in this article helpful to their research efforts on Spectrum Pharmaceuticals (Nasdaq: SPPI) regarding Zevalin®. <o:p> </o:p> <o:p> </o:p> <> As of March 16, 2009 , Zevalin® is now manufactured and sold in the <st1:country-region> <st1:place> US </st1:place> </st1:country-region> <> by Spectrum Pharmaceuticals (Nasdaq: SPPI ). Zevalin® is currently approved as a last resort treatment for refractory NHL. SPPI is seeking approval for Zevalin® as a first-line consolidation therapy for NHL. A FDA>>...
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