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Afinitor Approved for Advanced Breast Cancer

HealthDay – Fri, Jul 20, 2012 FRIDAY, July 20 (HealthDay News) -- Afinitor (everolimus) has been approved in combination with the drug exemestane to treat postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer, the U.S. Food and Drug Administration said Friday.

The newly approved combination is sanctioned for women whose cancer has progressed or returned despite previous use of the drugs letrozole (Femara) or anastrozole (Arimidex), the agency said in a news release.

Breast cancer, the second-leading cause of cancer death among women, is expected to be newly diagnosed in an estimated 226,870 women this year and cause about 39,510 deaths, the FDA said.

Afinitor -- already sanctioned for uses including treating certain forms of advanced renal cell carcinoma -- was clinically evaluated for the new use among 724 people with advanced breast cancer. People who took the combination drug had a 4.6-month improvement in the average time to disease progression or death, compared to those who took a placebo.

The most common side effects among those taking Afinitor were mouth ulcers, infection, rash, fatigue, diarrhea and loss of appetite.

Afinitor is marketed by Novartis, based in East Hanover, N.J.

More information

The National Cancer Institute has more about breast cancer.

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Kyprolis Approved for Multiple Myeloma

HealthDay – 1 hr 23 mins ago FRIDAY, July 20 (HealthDay News) -- Kyprolis (carfilzomib) has been approved by the U.S. Food and Drug Administration to treat certain people with multiple myeloma who have already been given at least two prior therapies.

Multiple myeloma is a form of cancer that arises from blood plasma, usually starting in the bone marrow, the agency said in a news release. More than 21,000 people in the United States are expected to be diagnosed with the disease this year, and about 10,700 will die from it, the American Cancer Society estimates.

Kyprolis has been approved for people treated previously with the anti-cancer drug bortezomib, and an immunomodulatory therapy such as thalidomide.

The most common side effects observed during clinical testing of Kyprolis included fatigue, low blood cell counts, low platelet counts, diarrhea and fever. More serious but less common adverse reactions included heart failure and shortness of breath, the FDA said.

Kyprolis is marketed by San Francisco-based Onyx Pharmaceuticals.

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Medline Plus has more about multiple myeloma.

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First Drug Approved to Lower Risk of Acquiring HIV

HealthDay – 2 hrs 2 mins ago TUESDAY, July 17 (HealthDay News) -- Truvada (emtricitabine/tenofovir disoproxil fumarate) is the first drug to be approved by the U.S. Food and Drug Administration to reduce the risk of contracting HIV among adults at higher risk of acquiring the AIDS-causing virus.

In a statement, the agency said Truvada was meant to be taken daily to reduce the chances of becoming HIV-infected among adults exposed to the virus. The agency previously approved Truvada in combination with other anti-viral drugs to treat HIV-infected people 12 years and older.

The FDA said it would strengthen the drug's label to warn that people who take the drug as a preventive should confirm they are not already HIV infected.

Truvada's safety and effectiveness were clinically evaluated among 2,499 HIV-negative gay men and transgender women "with evidence of high risk behavior for HIV infection," the agency said. Results showed the drug reduced HIV infection by 42 percent, compared with those who took a placebo.

A second study involved 4,758 heterosexual couples where one partner was infected, while the other was not. Truvada reduced the risk of transmitting infection by 75 percent, compared to those who took a placebo, the FDA said.

The most common side effects reported were diarrhea, nausea, abdominal pain, headache and weight loss. Most serious but less common adverse reactions included kidney or bone toxicity.

Drugmaker Gilead Sciences, based in Foster City, Calif., is required to conduct follow-up studies to evaluate long-term HIV resistance, and the drug's effects among pregnant women, the FDA said.

More information

To learn more about this disease, visit AIDS.gov.

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New Drug Approved for Colonoscopy Preparation

HealthDay – 2 hrs 1 min ago TUESDAY, July 17 (HealthDay News) -- Prepopik (sodium picosulfate, magnesium oxide and citric acid) has been approved by the U.S. Food and Drug Administration for adults preparing for a colonoscopy, a diagnostic procedure to inspect the colon's inner lining.

The cleansing regimen consists of two packets of powder, each dissolved in water, to be taken at different times before a colonoscopy, the FDA said in a news release. Additional fluid intake is needed to prevent dehydration and electrolyte imbalance, the agency warned.

In two clinical studies involving about 1,200 adults preparing for a colonoscopy, the most common side effects of Prepopik included nausea, headache and vomiting.

As a condition of approval, maker Ferring Pharmaceuticals must conduct additional studies to evaluate the product's safety and effectiveness among children, the FDA said.

Ferring is based in Parsippany, N.J.

More information

To learn more about colonoscopy, visit the National Digestive Diseases Information Clearinghouse.

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First Drug Approved to Lower Risk of Acquiring HIV

HealthDay – 2 hrs 1 min ago TUESDAY, July 17 (HealthDay News) -- Truvada (emtricitabine/tenofovir disoproxil fumarate) is the first drug to be approved by the U.S. Food and Drug Administration to reduce the risk of contracting HIV among adults at higher risk of acquiring the AIDS-causing virus.

In a statement, the agency said Truvada was meant to be taken daily to reduce the chances of becoming HIV-infected among adults exposed to the virus. The agency previously approved Truvada in combination with other anti-viral drugs to treat HIV-infected people 12 years and older.

The FDA said it would strengthen the drug's label to warn that people who take the drug as a preventive should confirm they are not already HIV infected.

Truvada's safety and effectiveness were clinically evaluated among 2,499 HIV-negative gay men and transgender women "with evidence of high risk behavior for HIV infection," the agency said. Results showed the drug reduced HIV infection by 42 percent, compared with those who took a placebo.

A second study involved 4,758 heterosexual couples where one partner was infected, while the other was not. Truvada reduced the risk of transmitting infection by 75 percent, compared to those who took a placebo, the FDA said.

The most common side effects reported were diarrhea, nausea, abdominal pain, headache and weight loss. Most serious but less common adverse reactions included kidney or bone toxicity.

Drugmaker Gilead Sciences, based in Foster City, Calif., is required to conduct follow-up studies to evaluate long-term HIV resistance, and the drug's effects among pregnant women, the FDA said.

More information

To learn more about this disease, visit AIDS.gov.

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Over-the-counter HIV test approved

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Approved Viagra copies flood drugstores in Korea

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Votrient Approved to Treat Cancer That Begins in Soft Tissue

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Levaquin Approved to Treat or Prevent Plague

HealthDay – 16 hrs ago FRIDAY, April 27 (HealthDay News) -- Approval of the antibiotic Levaquin (levofloxacin) has been expanded by the U.S. Food and Drug Administration to include plague, a rare but deadly bacterial infection.

The disease is extremely rare in the United States, and only about 1,000 to 2,000 cases occur each year across the globe, the agency said in a news release. The three most common forms of plague include bubonic (affecting the lymph nodes), pneumonic (lungs) and septicemic (blood stream).

Animals are most frequently infected, although plague can be spread to people by fleas, contact with infected animals or other people, or by exposure in the laboratory. The bacterium that causes plague, Yersinia pestis, is considered a potential bioterrorism agent, the FDA said.

Levaquin was tested under the agency's Animal Efficacy Rule, which allows findings from carefully controlled tests in animals to be applied to people. It would not be ethical or feasible to conduct clinical testing of the drug for this purpose in people, the FDA said.

Known side effects of Levaquin include nausea, headache, diarrhea, insomnia, constipation and dizziness. More serious but rare adverse reactions could include tendinitis and tendon rupture, allergic reactions, liver damage, blood and nervous system problems, and abnormal heart rhythm, the agency said.

Levaquin is produced by Raritan, N.J.-based Janssen Pharmaceuticals, a unit of Johnson & Johnson.

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Medline Plus has more about Levaquin.

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