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Latest US Food and Drug Administration Stories

2011-06-01 07:03:00

HERZLIYA, Israel, June 1, 2011 /PRNewswire-FirstCall/ -- On May 29, 2011 XTL has announced that its rHuEPO (recombinant human erythropoietin) drug which is currently in preparations for phase 2 clinical trial, has been granted an Orphan-drug designation by the US Food and Drug Administration (FDA) for treatment of Multiple Myeloma blood cancer. An orphan drug is defined as a drug treatment for an illness that affects a relatively small number of people in the population. In the US,...

2011-05-05 17:50:00

EAST HANOVER, N.J., May 5, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that the US Food and Drug Administration (FDA) approved Afinitor® (everolimus) tablets for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease(4). This marks the first approval of a treatment for this patient population in the US in nearly 30 years(5). The...

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2011-04-20 06:40:00

The US Food and Drug Administration (FDA) is requiring drugmakers to provide educational material to help train physicians on the correct use of drugs as part of the government's new plan to fight prescription drug abuse in the United States. Prescription drug overdose is the fastest-growing drug problem in the country. It is higher than the number of overdoses from the crack cocaine epidemic of the 80s and the black tar heroin epidemic of the 70s combined, the Obama administration says....

2011-04-12 13:59:00

EAST HANOVER, N.J., April 12, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that the US Food and Drug Administration (FDA) Oncologic Drugs Advisory Committee (ODAC) recommended approval of Afinitor® (everolimus) tablets for the treatment of patients with advanced neuroendocrine tumors (NET) of pancreatic origin. The recommendation was provided after presentation of data from the everolimus RADIANT (RAD001 In Advanced...

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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....


Word of the Day
tessitura
  • The prevailing range of a vocal or instrumental part, within which most of the tones lie.
This word is Italian in origin and comes from the Latin 'textura,' web, structure.