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FDA Approves Abbott's XIENCE(TM) V Drug Eluting Stent
Abbott today announced that the U.S. Food and Drug Administration (FDA) approved the XIENCE(TM) V Everolimus Eluting Coronary Stent System for the treatment of coronary artery disease.
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FDA Food Protection Plan Shows Significant Progress
The agency unveiled the plan just months ago to help keep Americans enjoying one of the safest food supplies in the world
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FDA Approves First Generic Risperidone to Treat Psychiatric Conditions
The U.S. Food and Drug Administration today approved the first generic versions of Risperdal (risperidone) tablets. Risperdal is an antipsychotic drug used for the treatment of schizophrenia, bipolar disorder, and other psychiatric conditions.
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New Drug Application for Inhaled Treprostinil Submitted to the U.S. Food and Drug Administration
United Therapeutics Corporation (Nasdaq:UTHR) and its wholly-owned subsidiary, Lung Rx, Inc., announced today the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for marketing approval of an inhaled formulation of treprostinil (ITRE) for the treatment of pulmonary arterial hypertension (PAH), a chronic, life-threatening disease.
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Impliant Restarts European Clinical Activities for Patented TOPS(TM) Spine System
Impliant, Inc., a developer of novel spine arthroplasty alternatives to fusion surgery, today announced that it has resumed European clinical activities on its TOPS(TM) System, a Total Posterior Arthroplasty device designed to treat spinal stenosis with or without facet arthrosis and spondylolisthesis.
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CDC Immunization Advisory Committee Recommends Two New Pediatric Vaccines from GlaxoSmithKline
Highlights Include: -- GSK's ROTARIX(R) [Rotavirus Vaccine, Live, Oral] recommended for routine vaccination of infants to protect against rotavirus gastroenteritis (RGE)
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U.S. FDA Licenses Sanofi Pasteur's New Pediatric Combination Vaccine, Pentacel(R)
Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, announced today that the U.S. Food and Drug Administration (FDA) has licensed Pentacel(R), Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine.
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FDA Requests Seizure of Animal Food Products at PETCO Distribution Center
Today, at the request of the U.S. Food and Drug Administration (FDA), U.S. Marshals seized various animal food products stored under unsanitary conditions at the PETCO Animal Supplies Distribution Center located in Joliet, Ill., pursuant to a warrant issued by the United States District Court in Chicago.
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FDA Approves Diaphragm-Pacing Device
The U.S. Food and Drug Administration today announced that it approved the NeuRx DPS RA/4 Respiratory Stimulation System, an implantable electronic device that stimulates the diaphragm and allows certain spinal cord injury patients to breathe for at least four hours a day without a mechanical ventilator.
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United States and China Outline Progress on Agreement on Food and Feed Safety
U.S. Secretary of Health and Human Services (HHS) Mike Leavitt signed a Joint Progress Statement today with the Honorable Li Changjiang, Minister of the General Administration of Quality Supervision, Inspection, and Quarantine (AQSIQ) of the People?s Republic of China.
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