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  • April 16- Momenta Pharmaceuticals Inc said the U.S. Food and Drug Administration approved the first generic version of Teva Pharmaceuticals Industries Ltd's top-selling multiple sclerosis drug, Copaxone. The agency cleared the application for the 20 mg version of the blockbuster drug, submitted by Momenta's partner Sandoz, a unit of Swiss drugmaker...

  • April 15- U.S. health regulators on Wednesday approved Amgen Inc's Corlanor to treat patients with chronic heart failure, giving the world's largest biotechnology company its first cardiovascular product. RBC Capital Markets analyst Michael Yee said that long term Corlanor could become a $500 million a year drug for Amgen. Amgen shares rose 1.3 percent in...

  • April 15- The Medicines Co's intravenous blood clot preventer can be used in angioplasty procedures, an independent advisory panel to the U.S. Food and Drug Administration said on Wednesday. The recommendation follows a review published by FDA staff on Monday, which supported the approval of the drug. Cangrelor, which won European approval in March, was...

  • April 15- The Medicines Co's intravenous blood clot preventer can be used in angioplasty procedures, an independent advisory panel to the U.S. Food and Drug Administration said on Wednesday. The panel voted 7-2 to support the approval of the injection, cangrelor, for use in certain patients undergoing angioplasty, a procedure to widen narrowed or clogged...

  • What is Kensho? Wednesday, 15 Apr 2015 | 12:00 AM ET
    Trader on the floor of the New York Stock Exchange.

    Get your market questions answered by data analytics firm Kensho on "Fast Money." Send questions on Twitter or Facebook using #Kensho.

  • WASHINGTON, April 14- AstraZeneca Plc's diabetes drug Onglyza and Takeda Pharmaceutical Co.' s rival product Nesina should carry information about the risk of heart failure, an advisory committee to the U.S. Food and Drug Administration said on Tuesday. The panel reviewed safety data on AstraZeneca's Onglyza and Takeda's Nesina. The studies were requested by...

  • April 14- An advisory panel to the U.S. Food and Drug Administration voted 13-3 that Takeda Pharmaceutical's diabetes drug Nesina should contain information about a potential increased risk of heart failure. The panel voted 16-0 that the drug has an acceptable overall cardiovascular safety profile, with no significant increased risk of major heart events...

  • The FDA issued the guidelines to help clarify what changes require regulatory approval under the 2009 Tobacco Control Act. The guidelines go far beyond that authority, the plaintiffs said, by requiring FDA authorization to make any labeling changes that would render a product already on the market "distinct," like a name change. Although the FDA has framed the...

  • A preliminary FDA review of Nesina, or alogliptin, showed a numerical increase in heart failure hospitalizations but not a statistically significant increase. Even so, some analysts expect the FDA to treat all drugs in the class the same way. "We believe the FDA will likely view the risk as likely to be a class effect and apply changes to all approved drugs in the...

  • WASHINGTON, April 14- AstraZeneca Plc's diabetes drug Onglyza should include new safety information about the risk of heart failure, a U.S. Food and Drug Administration advisory panel concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory panels but typically does so. A preliminary FDA review of the drug published on Friday noted an...

  • WASHINGTON, April 14- AstraZeneca Plc's diabetes drug Onglyza should include new safety information about the risk of heart failure, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The panel voted overwhelmingly that the drug's label should be changed to add information about an increased heart failure risk, but did not...

  • April 13- An intravenous blood clot preventer developed by The Medicines Co should be approved by the U.S. Food and Drug Administration, FDA staff reviewers concluded. The FDA rejected the blood thinner in April last year, after its reviewers took issue with the way a pivotal trial, called Champion- Phoenix, was conducted, and asked the company to reanalyze its...

  • CHICAGO, April 10- Sales of human antibiotics in the United States for use in livestock jumped by 20 percent between 2009 and 2013, federal regulators said on Friday, although recent statements by producers suggest those figures could be dropping. Companies such as Tyson Foods Inc and Perdue Farms have said in the past year, however, they have either reduced or...

  • April 10- Swedish Match AB should not be allowed to alter the warning label on its snus smokeless tobacco products to claim they are less harmful than cigarettes, an advisory panel to the U.S. Food and Drug Administration concluded on Friday. Stockholm- based Swedish Match is seeking FDA approval to remove warnings about mouth cancer, gum disease and tooth loss...

  • April 10- Swedish Match AB should not be allowed to alter the warning label on its snus smokeless tobacco products to claim they are less harmful than cigarettes, an advisory panel to the U.S. Food and Drug Administration concluded on Friday.

  • CHICAGO, April 10- Sales of medically important antibiotics in the United States for use in livestock jumped by 20 percent between 2009 and 2013, federal regulators reported on Friday, data that is sure to fuel concern that bacteria infecting humans could grow more resistant to the drugs. The U.S. Food and Drug Administration reported that domestic sales and...

  • U.S. meat industry buying more human antibiotics -FDA Friday, 10 Apr 2015 | 11:39 AM ET

    CHICAGO, April 10- Sales of medically important antibiotics in the United States for use in livestock jumped by 20 percent between 2009 and 2013, federal regulators reported on Friday, data that is sure to feed the national debate about the growth of drug-resistant bacteria. The U.S. Food and Drug Administration reported that domestic sales and distribution...

  • April 10- AstraZeneca Plc's diabetes drug Onglyza may be associated with an increased rate of death, according to a preliminary review of data by the U.S. Food and Drug Administration. The FDA's report, posted on the agency's website on Friday, comes ahead of an April 14 meeting of an FDA advisory panel to discuss the drug's safety. The FDA said the causes of death...

  • Britain's FTSE nears record high as Shire shines Friday, 10 Apr 2015 | 9:11 AM ET

    *FTSE 100 up 0.5 pct, near record highs. The FTSE 100 rose 0.5 percent to 7,051.07 points, close to a record 7,065.08 points reached in March. Shire shares rose 5.2 percent, the biggest gain on the FTSE 100, from a U.S. Food and Drug Administration decision to grant a priority review to its application for lifitegrast, a dry-eye disease treatment.

  • FDA stayed silent on hazardous diet pills: Report Wednesday, 8 Apr 2015 | 11:50 AM ET
    A Vitamin Shoppe store in New York.

    FDA never publicized that popular supplements contain a chemical nearly identical to amphetamine. New York Times reports.