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Latest US Food and Drug Administration Stories

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2009-05-18 13:30:00

The health risks attributed to smoking cigarettes appear to have actually worsened over time, according to a new study.Dr. David Burns of the University of California, San Diego, presented his findings during a meeting of the Society for Research on Nicotine and Tobacco.He noted that although the nation's rate of lung cancer has decreased as more people have kicked the habit, an individual smoker's risk of cancer is actually higher.Burns found a larger increase in a type of lung cancer called...

2009-05-06 17:37:00

ROCKVILLE, Md., May 6 /PRNewswire-FirstCall/ -- Vanda Pharmaceuticals Inc. (Nasdaq: VNDA) announced today that the US Food and Drug Administration (FDA) has granted marketing approval of Fanapt(TM) (iloperidone) for the acute treatment of adult patients with schizophrenia. The approval was supported by two placebo-controlled Phase III clinical studies comparing Fanapt(TM) to placebo and active control in patients with schizophrenia, as well as safety data from more than 3,000 patients....

2009-05-06 07:01:00

REHOVOT, Israel, May 6 /PRNewswire/ -- D-Pharm announced today that it has submitted IND and Special Protocol Assessment (SPA) packages to the US Food and Drug Administration (FDA), for its pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients. D-Pharm plans to initiate the trial later this year following FDA review of the IND and SPA. Recently, D-Pharm also obtained Scientific Advice from the European Medicines Agency (EMEA) on the development strategy for DP-b99...

2009-04-06 15:50:00

Agreement opens clear path to NDA for early diagnosis of Parkinsonian Syndromes HOPKINTON, Mass., April 6 /PRNewswire-FirstCall/ -- Alseres Pharmaceuticals, Inc. (Nasdaq: ALSE) announced today that it has reached agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) process for the Phase III protocol of Alseres' Altropane(R) Molecular Imaging Agent to aid in the early diagnosis of Parkinsonian syndromes including Parkinson's disease. A SPA...

2009-03-30 06:30:00

- Lorcaserin Very Well Tolerated Throughout Two-Year Study - Conference Call Scheduled for Today at 8:30 a.m. EDT SAN DIEGO, March 30, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today positive top-line results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and efficacy of lorcaserin for weight management. Statistical significance (p<0.0001) was...

2009-03-19 16:10:00

About Regulatory Issues in Telemedicine, Regenerative Medicine, More ROCKVILLE, Md., March 19 /PRNewswire-USNewswire/ --Six expert representatives from the US Food and Drug Administration (FDA) will be among the speakers to address several hundred healthcare product regulatory professionals who will gather in San Francisco next month. The Regulatory Affairs Professionals Society (RAPS) will convene its 2009 RAPS Horizons Conference & Exhibition, 1-3 April at The Fairmont San Francisco....

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2009-03-15 06:50:00

On Friday, US lawmakers introduced a bill that would ban the toxic chemical Bisphenol-A from food and beverage containers.The chemical, commonly referred to as BPA, is suspected of harming human development and has been blamed for many health problems in infants.The move comes on the heels of an announcement made by state officials that the top six baby bottle makers in the US were agreeing to stop using BPA in their products."The scientific evidence is mounting that BPA poses serious health...

2009-02-28 16:28:00

MINNEAPOLIS, Feb. 28 /PRNewswire/ -- In its ongoing contribution to science and the innovation of industry leading nutraceuticals, Eniva Nutraceutics announces the introduction of its new Eniva(R) Cholesterol Reducer(TM) formula. This advanced, liquid nutritional supplement is Eniva's newest heart health product, designed to support healthy cholesterol and homocysteine levels in the body.* The potent cholesterol lowering plant sterol formulation in the Eniva Cholesterol Reducer meets the...

2009-02-26 06:00:00

SOPHIA ANTIPOLIS, France, February 26 /PRNewswire-FirstCall/ -- NicOx S.A. (NYSE Euronext Paris: COX) today announced its financial results for full year 2008 and provided an overview of the development and pre-commercialization activities for naproxcinod, its lead investigational drug for the treatment of the signs and symptoms of osteoarthritis (OA). Michele Garufi, Chief Executive Officer of NicOx, commented: "We believe NicOx has entered 2009 in its strongest strategic position...

2009-02-19 06:48:00

PHILADELPHIA, Pennsylvania and DUBLIN, Ireland, February 19 /PRNewswire-FirstCall/ -- Shire plc (LSE: SHP, NASDAQ: SHPGY) the global specialty biopharmaceutical company announces results for the year to December 31, 2008 - a year which has seen significant growth in Shire's new product portfolio. Financial Highlights Full Year 2008 (1) Q4 2008 (1) Product sales $2.75bn + 27% $0.70 bn + 7%(3) Product...


Word of the Day
reremouse
  • A bat.
The word 'reremouse' comes from Middle English reremous, from Old English hrēremūs, hrērmūs ("bat"), equivalent to rear (“to move, shake, stir”) +‎ mouse.
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