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FDA APPROVES BIOGEN IDEC’S ELOCTATE™

Originally posted on Biogenidec.com FDA APPROVES BIOGEN IDEC’S ELOCTATE™, FIRST HEMOPHILIA A THERAPY TO EXTEND THE INTERVAL BETWEEN PROPHYLACTIC INFUSIONS, FOR BOTH ADULTS AND CHILDREN     – Only Hemophilia A Therapy to Provide Bleeding Protection with Prophylactic Infusions Every Three to Five Days – – Approval of Biogen Idec’s Second Innovative Hemophilia Therapy with… Read More »

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U.S. watchdog to review Lemtrada resubmission Originally posted at: http://www.reuters.com/article/2014/05/30/sanofi-lemtrada-idUSL6N0OG13O20140530   May 30 (Reuters) – French drug company Sanofi said on Friday the U.S. Food and Drug Administration (FDA) had agreed to review its U.S. unit Genzyme’s resubmission of its application for its Lemtrada drug for the treatment of relapsing forms of multiple sclerosis. A six-month review period… Read More »

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originally posted by WebMD Those who had gastric bypass dropped the most weight, some saw their type 2 diabetes disappear, studies found   Compared to diet and lifestyle changes, gastric bypass surgery appears to be the clear winner in helping obese people with type 2 diabetes lose weight and even rid themselves of the disease, new studies show. The findings “further… Read More »

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Originally posted on http://finance.yahoo.com/news/fda-clears-sensory-medical-relaxistm-140000927.html   FDA Clears Sensory Medical’s RelaxisTM, First Device for Restless Leg Syndrome   The U.S. Food and Drug Administration (FDA) has granted commercial clearance for RelaxisTM, the first non-pharmacological approach to help improve the quality of sleep in patients with primary Restless Leg Syndrome (RLS), it was announced today by Sensory Medical Inc.,… Read More »

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originally posted on www.fda.gov   FDA approves first implantable wireless device with remote monitoring to measure pulmonary artery pressure in certain heart failure patients   The U.S. Food and Drug Administration today approved the CardioMEMS HF System that measures the pulmonary artery (PA) pressures and heart rates of patients with New York Heart Association (NYHA)… Read More »

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originally posted on The Wall Street Journal AbbVie Receives Orphan Drug Designation for HUMIRA(R) (adalimumab) from the U.S. Food and Drug Administration for the Investigational Treatment of Certain Forms of Non-infectious Uveitis     NORTH CHICAGO, Ill., May 20, 2014 /PRNewswire/ — AbbVie (NYSE:ABBV) announced today that the U.S. Food and Drug Administration (FDA) has… Read More »

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FDA Approves Takeda’s Entyvio™ (vedolizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease   Originally posted on Reuters.com  – DEERFIELD, Ill. and OSAKA, Japan, May 20, 2014 Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food and Drug Administration… Read More »

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FDA Approves Takeda’s Entyvio™ (vedolizumab) for the Treatment of Adults with Moderately to Severely Active Ulcerative Colitis or Crohn’s Disease   Originally posted on Reuters.com  – DEERFIELD, Ill. and OSAKA, Japan, May 20, 2014 Takeda Pharmaceutical Company Limited (“Takeda”) and its wholly-owned subsidiary, Takeda Pharmaceuticals U.S.A., Inc., today announced that the United States (U.S.) Food and Drug Administration… Read More »

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originally posted by MPR Decipher Test Impacts Post-Op Tx Choice for Prostate Cancer   GenomeDx Biosciences announced data from two studies showing that Decipher Prostate Cancer Classifier significantly altered treatment decisions and increased confidence in treatment decision-making for men considering adjuvant therapy following prostate surgery. The Decipher Prostate Cancer Classifier assesses the activity of multiple genomic markers… Read More »

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originally posted on MPR DEKA Integrated Solutions has received FDA marketing approval for the DEKA Arm System, the first prosthetic arm that can perform multiple, simultaneous powered movements controlled by electrical signals from electromyogram (EMG) electrode in individuals with upper extremity amputations occurring at the shoulder joint, mid-upper arm, or mid-lower arm. The DEKA Arm… Read More »

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