Latest US Food and Drug Administration Stories
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.
EAST HANOVER, N.J., May 5, 2011 /PRNewswire/ -- Novartis Pharmaceuticals Corporation ("Novartis") announced today that the US Food and Drug Administration (FDA) approved AfinitorÂ® (everolimus) tablets for the treatment of progressive neuroendocrine tumors of pancreatic origin (PNET) in patients with unresectable, locally advanced or metastatic disease(4).
The FDA is requiring drugmakers to provide educational material to help train physicians on the correct use of drugs as part of the governmentâ€™s new plan to fight prescription drug abuse in the United States.
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 AfinitorÂ® (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 Neuroendocrine Tumors) trial...
Drug maker GlaxoSmithKline released a new report detailing that its antidepressant Paxil could potentially make people with major depression more likely to become suicidal.
A new drug shown to help prolong the lives of people suffering from advanced skin cancer has been approved by the FDA.
WAYNE, N.J., March 25, 2011 /PRNewswire/ -- Bayer HealthCare Pharmaceuticals Inc.
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.
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.
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