FDA Response to iCAD’s 510(K) Anticipated (Nasdaq:ICAD)
iCAD, Inc. (Nasdaq:ICAD) discovers, develops and then brings into market “advanced image analysis and workflow solutions†that allow cancer to be detected in the initial stages.
Continue reading...Bayer to present filing strategy (OTC:BAYRY.PK), (ETR:BAYN)
1 March 2010
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Bayer HealthCare, which is a subsidiary of Bayer AG (OTC:BAYRY.PK), is developing a drug called – Rivaroxoban (having a brand name Xarelto™) – jointly with Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Continue reading...Lannett to submit NDA (AMEX:LCI)
1 March 2010
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Products comprising of Morphine Sulfate have been developed by the Lannett Company, Inc. (AMEX:LCI). These products had been produced and later distributed by the company for several years.
Continue reading...Results from PH-10′s Phase 2 trial expected (NASDAQ:PVCT.OB)
1 March 2010
Provectus Pharmaceuticals, Inc. (NASDAQ:PVCT.OB) is a biopharmaceutical company that discovers, develops and then commercializes drugs for cancers (such as skin cancer or melanoma, liver cancer and breast cancer) and skin diseases (such as eczema or atopic dermatitis, psoriasis and acme).
Continue reading...Shire PDUFA date expected (LSE:SHP, NASDAQ:SHPGY)
1 March 2010
On November 4, 2009, Shire plc (LSE:SHP, NASDAQ:SHPGY), which is a specialty biopharmaceutical company that is operating in several countries worldwide, disclosed to its stockholders that the Food and Drug Administration had assigned its New Drug Application (NDA) the status of Priority Review.
Continue reading...PDUFA Date Set For Tomorrow February 23 (NASDAQ:SLXP)
22 February 2010
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On August 24, 2009, Salix Pharmaceuticals, Ltd. (NASDAQ:SLXP) disclosed that the FDA had found that new drug application (NDA) – that was submitted for the company’s recently developed rifaximin tablets 550 mg – contained all the information that would allow it to make a thorough review – that is, the NDA was accepted for filing.
Continue reading...FDA’s response to ProUroCare Medical Anticipated on February 23 (OTC:PUMD)
22 February 2010
On November 23, 2009, ProUroCare Medical Inc. (OTC:PUMD) , (OTC:PUMDU) and (OTC:PUMDW), which discovers, develops and markets novel products for medical imaging, disclosed to its stockholders
Continue reading...FDA Response to CPI-300′s NDA Anticipated Soon (NASDAQ:IGXT)
4 February 2010
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CPI-300 is a drug that has been developed by IntelGenx Corp. (NASDAQ:IGXT.OB) and its partner, Cary Pharmaceuticals, Inc, under the Collaborative Agreement signed by the two companies in 2007. The drug is used as an antidepressant with an increased strength and can be used to treat disorders associated with depression.
Continue reading...FDA Response to ODFS’s NDA Anticipated (NYSE:PRX)
4 February 2010
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Strativa Pharmaceuticals is a subsidiary owned by the Par Pharmaceutical Companies, Inc. (NYSE:PRX), a specialty pharmaceutical company that is involved in the development, manufacturing and commercialization of both generic drugs and novel branded drugs.
Continue reading...FDA response on Autologel Sytem Expected Soon (AMEX:GTF)
4 February 2010
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On August 7, 2009, Cytomedix, Inc. (NYSE AMEX:GTF) announced that it has submitted to, the United Sates of America’s toughest regulator, the Food and Drug Administration (FDA) a 510(K) for its AutoloGel™ Platelet Separation System.
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1 March 2010
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