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Washington Editor Despite a prior refusal, Pharmacyclics Inc. is filing a new drug application for Xcytrin (motexafin gadolinium)...
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Staff Writer While awaiting FDA approval of its beta-blocker PW2101 for hypertension and angina, Penwest Pharmaceuticals Co. entered...
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West Coast Editor One month away from an FDA panel review, GPC Biotech Inc.'s satraplatin for prostate cancer...
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Staff Writer Praecis Pharmaceuticals Inc. continues to expect regulatory approval for Plenaxis despite an FDA decision to delay...
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Staff Writer With an FDA decision expected by the end of next month on the antisense drug Genasense...
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Washington Editor Factive (gemifloxacin) will get an expanded label in pneumonia, according to an FDA approvable letter, and...
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Washington Editor ROCKVILLE, Md. - An FDA advisory panel Friday leaned toward favoring Macugen, a proposed treatment for...
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Washington Editor FDA reviewers agree that Genentech Inc. 's first-in-class monoclonal antibody for allergic asthma is associated with...
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Washington Editor Nearly two years after an FDA advisory panel rejected its application for use of Symlin as...
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Washington Editor GAITHERSBURG, Md. - An FDA advisory panel said Xolair appears to work well enough in moderate...
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Atrix Laboratories Inc., of Fort Collins, Colo., submitted an investigational new drug application to the FDA for a...
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Washington Editor SILVER SPRING, Md. - An FDA advisory panel provided late-stage lung cancer patients with a ray...
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Staff Writer Amgen Inc. on Tuesday received positive word from an FDA advisory panel regarding Enbrel (etanercept), which...
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Pfizer Inc. ( NYSE: PFE ) announced that the U.S. Food and Drug Administration's (FDA) Antiviral Drugs Advisory...
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The US Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee announced it will hold a...
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Washington Editor A drug developed in part by the Speedel Group, SPP100 (aliskiren),now is under FDA review after...
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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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Washington Editor MGI Pharma Inc. filed for FDA approval of Saforis, an oral formulation of the amino acid...
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Senior Staff Writer Nastech Pharmaceutical Co. Inc. 's stock continued to fall Friday after it announced one day...
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Alkermes Inc., of Cambridge, Mass., said its new drug application for Vivitrex (naltrexone long-acting injection) has been granted...
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