FDA Approvals
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Washington Editor Santarus Inc. won FDA approval of Rapinex, an immediate-release formulation of the proton pump inhibitor omeprazole,...
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Staff Writer Nearly two years after the company filed its new drug application, Orphan Medical Inc. said after...
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Invatec, a comprehensive innovator of interventional products, announced that it has received 510(k) clearance from the U.S. Food...
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Staff Writer More than two years after filing a new drug application for Fortical, Unigene Laboratories Inc. received...
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Staff Writer Indevus Pharmaceuticals Inc. filed with the FDA seeking approval of Nebido, an injectable three-month formulation of...
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Washington Editor Genzyme General received FDA approval of the orphan drug Fabrazyme, an enzyme replacement therapy for a...
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Quotient Biodiagnostics, Inc., announced that the U.S. Food and Drug Administration (FDA) has approved its biologics license application...
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Staff Writer Vivus Inc. won FDA approval of its Evamist product, triggering a $140 million milestone payment from...
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The following information was released by the American Academy of Family Physicians: The FDA has approved revisions to...
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Ortho Clinical Diagnostics announced U.S. Food and Drug Administration (FDA) approval of a diagnostic assay for the detection...
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Washington Editor WASHINGTON - New legislation to empower the FDA to define pathwaysfor biogeneric approvals is on the...
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Senior Staff Writer A little more than a year after Abraxane gained FDA approval as a treatment for...
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Washington Editor WASHINGTON - A study conducted by a Washington think tank with ties to managed care is...
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o Acceleron Pharma Inc., of Cambridge, Mass., initiated a Phase I trial of ACE-011, a regenerative therapeutic for...
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o Auxilium Pharmaceuticals Inc., of Malvern, Pa., received clearance from the FDA to resume its phase III clinical...
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West Coast Editor Having settled a legal spat with former Fortigel partner PDI Inc., Cellegy Pharmaceuticals Inc. is...
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o Adolor Corp., of Exton, Pa., and GlaxoSmithKline, of London, said the FDA has requested additional data be...
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Staff Writer Shares of Avanir Pharmaceuticals Inc. shot up 309 percent Wednesday after the company announced positive top-line...
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West Coast Editor Amgen Inc. 's Aranesp (darbepoetin alpha) for oncology applicationswon FDA approval, and the competitive race...
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o Avicena Group Inc., of Palo Alto, Calif., initiated a Phase I study of the neuroprotective agent AL-02...
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