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  • Dec 11- Pfizer Inc's antipsychotic Geodon and generic versions of the drug can trigger a potentially fatal skin reaction, the U.S. Food and Drug Administration warned on Thursday. A new warning has been added to the drug's label to describe the condition- known as Drug Reaction with Eosinophilia and Systemic Symptoms- which may start as a rash and spread all over.

  • Arca's potential Ebola drug gets "orphan drug status" Wednesday, 10 Dec 2014 | 11:19 AM ET

    Dec 10- Arca Biopharma Inc said the U.S. Food and Drug Administration granted its experimental drug orphan drug status as a potential treatment for viral hemorrhagic fever after exposure to the Ebola virus. The Westminster, Colorado- based company, whose stock rose about 11 percent on Wednesday, joins a list of drugmakers looking for ways to fight the largest...

  • LONDON, Dec 10- Drugmakers are finally getting more bang for their scientific buck, with the rate of return on pharmaceutical research and development increasing for the first time since 2010.. So far this year the U.S. Food and Drug Administration, which acts as gatekeeper to the world's biggest market, has approved 35 new products, up from 27 in the whole of 2013...

  • Dec 8- Medical device maker Stryker Corp will pay the U.S. government $80 million to settle criminal and civil charges that its OtisMed Corp subsidiary sold devices used in knee replacement surgery without approval from the U.S. Food and Drug Administration. The company sold more than 18,000 OtisKnee cutting guides- which are designed to help surgeons make...

  • Dec 8- Medical device maker Stryker Corp will pay the U.S. government $80 million to settle charges that its OtisMed Corp subsidiary sold devices used in knee replacement surgery without approval from the U.S. Food and Drug Administration. The company sold more than 18,000 OtisKnee cutting guides- which are designed to help surgeons make accurate bone cuts in...

  • NEW YORK, Dec 8- U.S. health regulators estimate that consumers will suffer up to $5.27 billion in "lost pleasure" over 20 years when calorie counts on restaurant menus discourage people from ordering french fries, brownies and other high-calorie favorites. The FDA said the analysis balances the benefits to consumers when calorie information leads them to eat...

  • Dec 3- U.S. health regulators on Wednesday approved an Amgen Inc drug that helps the immune system fight a rare type of leukemia, more than five months ahead of the expected decision date. Anthony Stein, professor of hematology at City of Hope outside Los Angeles who worked on clinical trials of blinatumomab, called the approval "very important" for patients.

  • Dec 2- The U.S. Food and Drug Administration changed the rules governing how prescription drugs and biologics used during pregnancy and breastfeeding are labeled. The decision, which has been in the works since 2008, will impact more than 6 million pregnancies in the United States involving women who, on average, need to take three to five prescription drugs...

  • FDA panel says newer HIV tests effective Tuesday, 2 Dec 2014 | 5:00 PM ET

    Dec 2- Newer methods to test donated blood samples for HIV infections are effective, a panel of experts at the U.S. Food and Drug Administration concluded, in a move that could limit the ban on donations by men who have had sex with other men. The FDA's ban, in place for about three decades, disallows donations from men who have had sex with even one man since 1977, as they...

  • Dec 1- The U.S. Food and Drug Administration lifted a clinical hold on Flexion Therapeutics Inc's lead experimental drug to relieve osteoarthritis-related pain, allowing the company to resume its mid-stage trial. Osteoarthritis is one of the most common forms of arthritis in the United States and affects about 27 million Americans. Up to Monday's close,...

  • FDA lifts hold on Flexion's lead drug Monday, 1 Dec 2014 | 5:12 PM ET

    Dec 1- The U.S. Food and Drug Administration lifted a clinical hold on Flexion Therapeutics Inc's lead experimental drug to relieve osteoarthritis-related pain, allowing the company to resume mid-stage trials. The agency had halted trials of the injectable drug, FX006, in September after one patient's knee was infected. Flexion said it also plans to initiate a...

  • FDA rejects Avanir's migraine drug-device Wednesday, 26 Nov 2014 | 5:30 PM ET

    Nov 26- The U.S. Food and Drug Administration rejected Avanir Pharmaceuticals Inc's migraine drug device, a few weeks after the regulator had raised questions regarding some data submitted as part of the marketing application. Earlier this month the FDA had asked Avanir to assess the root cause of errors observed in the data from the drugmaker's human factors...

  • Bristol-Myers said it had initially sought permission from the U.S. Food and Drug Administration to market the drug, a so-called NS5A inhibitor, in combination with asunaprevir, one of the New York- based company's experimental medicines. But Bristol-Myers abandoned its U.S. marketing application for asunaprevir in October because of potential...

  • FDA declines to approve Bristol-Myers hepatitis drug Wednesday, 26 Nov 2014 | 11:56 AM ET

    Nov 26- Bristol-Myers Squibb Co on Wednesday said U.S. regulators had declined to approve use of its experimental daclatasvir drug for hepatitis C, in combination with other antiviral drugs.

  • Searching for relief from expensive generic drugs Tuesday, 25 Nov 2014 | 2:24 PM ET
    Senator Amy Klobuchar

    Generic drug costs have risen so much that some drugs have surpassed their equivalents in other developed countries, the New York Times reports.

  • New FDA rules will put calorie counts on menus Tuesday, 25 Nov 2014 | 3:43 AM ET
    Water menu at Ray's and Stark in Los Angeles.

    Whether they want to or not, consumers will soon know how many calories they are eating when ordering off the menu at chain restaurants.

  • FDA approves Purdue's painkiller that can reduce abuse Thursday, 20 Nov 2014 | 1:46 PM ET

    Nov 20- The U.S. Food and Drug Administration has approved a long-acting narcotic painkiller with abuse-resistant properties made by Purdue Pharma L.P., the agency said on Thursday. The FDA approved the once-daily drug, Hysingla ER, with the expectation that it will reduce, though not necessarily prevent, abuse through snorting or injecting.

  • Nov 20- A U.S. court has denied a request by Indian drugmaker Ranbaxy Laboratories Ltd to stop competitors from launching copies of AstraZeneca Plc's heartburn pill Nexium and Roche's antiviral, a court filing showed. Ranbaxy had filed a lawsuit against the U.S. Food and Drug Administration last week for revoking tentative approvals it gave the company to make...

  • Nov 19- Pharmaceutical investment firm Royalty Pharma said it would buy royalties on Vertex Pharmaceuticals Inc's cystic fibrosis treatments from Cystic Fibrosis Foundation for $3.3 billion in cash. Vertex's cystic fibrosis drug, Kalydeco, was approved by the U.S. Food and Drug Administration in January 2012. Vertex co-developed the drug with an affiliate...

  • Gift of sight  Wednesday, 19 Nov 2014 | 1:41 PM ET

    Second Sight's main product "The Argus II" has been helping people who are blind see again. Second Sight patient Fran Fulton, and Second Sight CEO Dr. Robert Greenberg, discuss the technology.