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Government Agencies FDA

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  • June 24- The U.S. Food and Drug Administration said it would discuss the safety and effectiveness of Bayer AG's controversial contraceptive device, Essure, in a public panel meeting after receiving more than 5000 complaints, including those of deaths and pregnancies. The FDA approved the device in November 2002. The FDA said it plans to hold a meeting of the...

  • FDA approves new Medtronic's heart valve device Tuesday, 23 Jun 2015 | 3:29 PM ET
    Medtronic Chairman and Chief Executive Omar Ishrak.

    The CEO of Medtronic talks new FDA approval and how to improve the health-care system.

  • June 23- Medtronic Inc said the U.S. Food and Drug Administration approved a new version of its non-invasive heart valve replacement device, making it the first recapturable and repositionable device available in the United States. The device has a smaller delivery system than the previous version, which means it can be used to treat patients with smaller...

  • June 22- The U.S. Food and Drug Administration on Monday approved Medicines Co's blood clot preventer Cangrelor, which has faced multiple setbacks since it first entered late-stage studies close to a decade back. Medicines Co has funneled about $200 million into developing Cangrelor over the past decade, which included two unsuccessful trials and a pivotal...

  • June 22- The U.S. Food and Drug Administration approved Medicines Co's blood clot preventer Cangrelor on Monday, close to a decade after the drug first entered late-stage studies.

  • Mount Sinai CEO sees doom in looming Obamacare case Saturday, 20 Jun 2015 | 9:00 AM ET
    Supporters of the Affordable Care Act gather in front of the U.S Supreme Court during a rally in Washington last March.

    Mount Sinai's CEO sees a "death spiral" could occur if the Supreme Court rules against the health insurance subsidies in Obamacare.

  • June 18- Amgen Inc said its drug met the main goal of improving overall survival in metastatic colorectal cancer patients who have not responded to chemotherapy. The U.S. Food and Drug Administration approved Vectibix in 2006 as a standalone treatment for metastatic colorectal cancer. Colorectal cancer affects about 1.2 million people worldwide each year,...

  • Inspectors from the FDA and other federal agencies screened and seized illegal drugs and medical devices received through international mail facilities in Chicago, Miami and New York, the FDA said in a statement. The prescription drugs targeted included some purported to be the generic versions of FDA- approved drugs such as Nolvadex, Meridia, Valium, Truvada...

  • Under new FDA regulations, partially hydrogenated oils, which have been shown to raise "bad" LDL cholesterol, will be considered food additives that cannot be used unless authorized by the FDA. The regulations take effect in three years, giving companies time to either reformulate products without partially hydrogenated oils or petition the FDA to permit...

  • June 16- The U.S. Food and Drug Administration on Tuesday made good on its proposal to effectively ban artificial trans fats from a wide range of processed foods, from microwave popcorn to frozen pizza, saying they raise the risk of heart disease. Under new FDA regulations, partially hydrogenated oils, which have been shown to raise "bad" LDL cholesterol, will be...

  • June 15- RedHill Biopharma Ltd said its experimental drug met the main goal of eradicating a bacterial infection in a late-stage study. RedHill said it plans to meet with the U.S. Food and Drug Administration to discuss the clinical and regulatory path for RHB-105. Roth Capital analysts in a note last week pegged peak sales for the drug at around $100 million to...

  • June 12- The U.S. Food and Drug Administration said it approved a brain implant from St. Jude Medical Inc that helps reduce symptoms of Parkinson's disease and essential tremor, a neurological disorder that causes rhythmic shaking. The device can be used when medication alone may not provide adequate relief from symptoms such as walking difficulties, balance...

  • Quick, cheap way to help stop deadly Ebola Friday, 12 Jun 2015 | 3:10 PM ET
    Red Cross workers carry away a person suspected of dying from Ebola, in the Liberian capital Monrovia, on October 4, 2014.

    OraSure Technologies' test, which takes 20 minutes for results, could help stop the spread of Ebola in an outbreak.

  • Listeria outbreak freezes Blue Bell Thursday, 11 Jun 2015 | 8:00 AM ET
    Listeria outbreak freezes Blue Bell

    Blue Bell identified the source of the listeria outbreak at its Oklahoma facility as one unsanitary room.

  • ZURICH, June 11- The U.S. Food and Drug Administration is testing samples of a Nestle instant noodle brand that was recalled from stores across India last week, a spokeswoman for the Swiss food group said on Thursday. A spokeswoman for the Swiss-based company said the United States' FDA was now also looking into the issue. "We have been made aware that the FDA has taken...

  • ZURICH, June 11- The U.S. Food and Drug Administration is testing samples of a Nestle instant noodle brand that was recalled from stores across India last week, a spokeswoman for the Swiss food group said on Thursday. A spokeswoman for the Swiss-based company said the United States' FDA was now also looking into the issue. "We have been made aware that the FDA has taken...

  • LOS ANGELES, June 10- A U.S. government inspection of food service facilities at Los Angeles International Airport found dirty employee bathrooms and food preparation issues, according to documents made public on Wednesday by a union representing airline food workers. The report from a Food and Drug Administration inspection conducted in January was...

  • Insulet gets FDA warning letter over some insulin pumps Wednesday, 10 Jun 2015 | 6:05 PM ET

    June 10- Insulet Corp said on Wednesday it received a warning letter from the U.S. Food and Drug Administration over some of the company's insulin pumps. The company said the letter, which it received on Monday, followed an inspection by the FDA of its facility in Billerica, Massachusetts in March. The letter relates to the release of certain lots of the company's...

  • Why a FDA nod isn't enough for Regeneron shares Wednesday, 10 Jun 2015 | 12:49 PM ET
    A technician at Regeneron Pharmaceuticals headquarters in Tarrytown, N.Y.

    Regeneron's shares sank 4 percent despite a positive Food and Drug Administration recommendation on a cholesterol drug. What gives?

  • 10 drugs to hit fed budget by $50B over decade Tuesday, 9 Jun 2015 | 1:42 PM ET
    Health Care

    Ten so-called breakthrough drugs for cancers and chronic conditions will cost taxpayers big bucks.