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Latest US Food and Drug Administration Stories

2009-07-07 06:00:00

BRISTOL, Tenn. and SAN MATEO, Calif., July 7 /PRNewswire-FirstCall/ -- King Pharmaceuticals, Inc. (NYSE: KG) and Pain Therapeutics, Inc. (Nasdaq: PTIE) today announced that on July 2, 2009, King met with the US Food and Drug Administration (FDA) to discuss the Complete Response Letter regarding the New Drug Application (NDA) for REMOXY(R). The outcome of this meeting provided King with a clear path forward to resubmit the REMOXY(R) NDA and to address all FDA comments in the Complete Response...

2009-06-08 07:00:00

REHOVOT, Israel, June 8 /PRNewswire/ -- D-Pharm announced today that its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients has been approved by the US Food and Drug Administration (FDA). D-Pharm plans to initiate the trial in the coming months, in over 100 clinical sites in North America, Europe, South Africa and Israel. The forthcoming Phase III trial is a randomized, double blind, placebo-controlled study...

2009-06-06 10:00:00

- Late-Breaking Data from Pivotal BLOOM Trial Presented at the American Diabetes Association's 69th Scientific Sessions Expand on Previously Announced Positive Top-Line Results - NEW ORLEANS, June 6, 2009 /PRNewswire-FirstCall/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today a late-breaking poster presentation of positive results from BLOOM (Behavioral modification and Lorcaserin for Overweight and Obesity Management), the first of two pivotal trials evaluating the safety and...

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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...


Word of the Day
attercop
  • A spider.
  • Figuratively, a peevish, testy, ill-natured person.
'Attercop' comes from the Old English 'atorcoppe,' where 'atter' means 'poison, venom' and‎ 'cop' means 'spider.' 'Coppa' is a derivative of 'cop,' top, summit, round head, or 'copp,' cup, vessel, which refers to 'the supposed venomous properties of spiders,' says the OED. 'Copp' is still found in the word 'cobweb.'
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