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Latest US Food and Drug Administration Stories

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2011-04-01 07:40:00

Drug maker GlaxoSmithKline released a new report detailing that its antidepressant Paxil could potentially make people with major depression more likely to become suicidal. But in clinical trials, the company found that attempted suicide rates were relatively low -- 0.34 percent for those using Paxil vs. 0.05 percent for those taking a placebo pill. The report also states that the findings couldn't rule out that the difference was due to chance. "The scientific evidence does not establish...

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2011-03-26 08:45:00

A drug from Bristol-Myers Squibb Co. shown to help prolong the lives of people suffering from advanced skin cancer has been approved by the US Food and Drug Administration on Friday.The injectable drug, called Yervoy (ipilimumab), is used for late-stage melanoma. Bristol-Myers Squibb aims to use the drug to harness the body's immune system to target and attack melanoma tumors."Yervoy is the first therapy approved by the FDA to clearly demonstrate that patients with metastatic melanoma live...

2011-03-25 09:49:00

WAYNE, N.J., March 25, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc. today announced that interim results from a large, prospective, observational cohort safety study offer insights into the increased risk of venous thromboembolism (VTE), or blood clots, which is a well-established risk in women who use combination oral contraceptives (COCs), also known as "the Pill". Specifically, the new data provides healthcare providers with information regarding when the VTE risk...

2011-03-22 00:00:28

Following the recent FDA approval of the expanded LAP-BAND® System indication for patients with lower weight requirements, DayOne Health, a leading Chicago outpatient weight loss program, is now offering an affordable self-pay option for the newly qualified low BMI LAP-BAND® patients. DayOne Health is thrilled to be able to focus on the procedure's preventive value and help seriously overweight Chicago patients who did not previously qualify for this weight loss surgery. Chicago, IL...

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2011-03-10 11:15:00

A drug for high-risk pregnant women that once cost between $10 to $20 per injection will next week cost $1,500 a dose, meaning the total cost during a pregnancy could be as much as $30,000. Makena, a form of progesterone given as a weekly shot, has been mixed inexpensively for years in special pharmacies that mix custom-compounds that are not federally approved, according to an Associated Press (AP) report. Doctors predict the price hike may deter low-income women from getting the treatment...

2011-03-09 06:30:00

MONMOUTH JUNCTION, N.J., March 9, 2011 /PRNewswire/ -- Tris Pharma, a specialty pharmaceutical company that develops innovative drug delivery technologies, announced today that the US Food and Drug Administration (FDA) has accepted its Extended Release Carbinoxamine Oral Suspension NDA for the treatment of allergies in kids two years and older. If approved, Tris Pharma's Extended Release Suspension will provide an alternative to the currently available immediate release formulations....

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2011-02-28 06:30:00

Reynolds and Lorillard, the second- and third-biggest US cigarette makers, filed suit to block the US Food and Drug Administration (FDA) from receiving recommendations from an advisory committee that the cigarette makers claim have conflicts of interest, Reuters is reporting. Reynolds, a unit of Winston-Salem, North Carolina-based Reynolds American Inc., makes Camel and Winston cigarettes in addition to its Kool and Salem menthol brands. Lorillard Tobacco is a unit of Lorillard Inc., based...

2011-02-09 16:10:00

EAST HANOVER, N.J., Feb. 9, 2011 /PRNewswire/ -- The New England Journal of Medicine (NEJM) published a study today that shows Afinitor® (everolimus) tablets plus best supportive care (BSC) more than doubled progression-free survival (PFS), or time without tumor growth, versus placebo plus BSC in patients with advanced pancreatic neuroendocrine tumors (NET)(1). Data from the study, RADIANT-3 (RAD001 In Advanced Neuroendocrine Tumors), were first presented last year at...

2011-02-02 15:49:00

Contrave Disallowed Pending Further Large-Scale Testing SILVER SPRING, Md., Feb. 2, 2011 /PRNewswire-USNewswire/ -- In its latest blow to obesity medication development efforts, the US Food and Drug Administration (FDA) yesterday notified Orexigen Therapeutics that it would need to conduct an extremely large-scale study of the long-term cardiovascular effects of its drug, Contrave, before approval could be considered. The economics of such a trial make it extremely unlikely that it can be...

2011-01-27 15:05:00

SAN DIEGO, Jan. 27, 2011 /PRNewswire/ -- Arena Pharmaceuticals, Inc. (Nasdaq: ARNA) announced today a reduction of its US workforce of approximately 25%, or 66 employees. As a result of the workforce reduction, which Arena plans to complete around March 28, 2011, the company expects to incur restructuring charges, primarily in the first quarter of 2011, of approximately $3.8 million in connection with one-time employee termination costs. Arena expects the reduction to decrease annualized...


Word of the Day
mundungus
  • A stinking tobacco.
  • Offal; waste animal product; organic matter unfit for consumption.
This word comes from the Spanish 'mondongo,' tripe, entrails.