Haemonetics product gets FDA approval
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THE REGION Haemonetics Corp.'s CardioPat autotransfusion system has received marketing clearance from the Food and Drug Administration. The blood recovery systems maker said it will begin customer acceptance trials in the United States immediately, and expects full market release this year. CardioPat allows surgeons to recover blood lost during and after surgery, and to make the blood available for transfusion ...
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TORONTO - A new but potentially costly treatment for multiple sclerosis has received fast-track approval from the US Food and Drug Administration.
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The FDA approves use of the Myomo e100 NeuroRobotic System, a high-tech gizmo that gives weakened limbs a boost and helps retrain damaged neurological pathways.
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A new device to treat uterine  fibroids -- fibrous clumps that can cause miscarriages, painful  menstruation and other related problems in women -- won U.S.  regulatory approval on Friday.
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Early yesterday evening, Biogen IDEC (Nasdaq: BIIB) and Elan (NYSE: ELN) announced that Tysabri had been approved by the FDA for the treatment of multiple sclerosis (MS).
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Biotech giant Inc. Amgen and the pharmaceuticals division of health-care products company Wyeth said Tuesday the Food and Drug Administration approved their arthritis treatment Enbrel to induce a major clinical
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A new device to treat uterine fibroids -- fibrous clumps that can cause miscarriages, painful menstruation and other related problems in women -- won US regulatory approval on Friday.
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India's Ranbaxy Laboratories Ltd. has received the U.S. Food and Drug Administration's approval for clarithromycin, a generic form of Abbott Laboratories Inc.'s antibiotic Biaxin, the FDA said on Saturday.
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Forest and Mylan receive FDA approval for Bystolic.
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LOS ANGELES/NEW YORK  - The U.S. Food and Drug   Administration said on Wednesday it had approved Amgen Inc.'s   drug Vectibix for use in colon cancer patients whose tumors   have spread despite chemotherapy treatment.
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AstraZeneca Plc  has won U.S.  approval for its asthma drug Symbicort, significantly earlier  than most industry analysts had expected, a person familiar  with the matter said on Saturday.
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The Food and Drug Administration has approved a new drug for multiple sclerosis that in clinical trials got better results than existing drugs in protecting against relapses.
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The EU market welcomes the drugmaker's copy of a treatment for anemia.
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The Food and Drug Administration yesterday approved a drug for multiple sclerosis that has shown early evidence of being more effective than existing drugs.
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Medtronic Inc., a maker of implantable medical devices, said Monday that it received Food and Drug Administration approval for its InSync Sentry implantable defibrillator system.
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Shares of Boston Scientific (BSX:NYSE - news - research) rose Monday following the announcement that the Food and Drug Administration had approved its product to reduce the risk of a heart attack following heart bypass surgery.
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Medical device company Boston Scientific Corp. said Wednesday the Food and Drug Administration granted the company US marketing clearance for its peripheral cutting balloon microsurgical dilation device to improve blood flow to diseased kidneys.