GO
Loading...

FDA

More

  • Halozyme shares jump after FDA lifts hold on trial Thursday, 5 Jun 2014 | 7:52 AM ET

    June 5- Shares of Halozyme Therapeutics Inc jumped about 11 percent a day after the U.S. Food and Drug Administration lifted a hold on a trial testing an advanced version of the company's flagship drug delivery technology.

  • June 4- HeartWare International Inc said it received a warning letter from the U.S. Food and Drug Administration following an inspection of its manufacturing plant in Florida in January. HeartWare has also been asked to address issues related to its production and quality procedures and fix problems cited in FDA's inspection.

  • Medical device maker HeartWare gets FDA warning letter Wednesday, 4 Jun 2014 | 7:37 AM ET

    June 4- HeartWare International Inc said it received a warning letter from the U.S. Food and Drug Administration following an inspection of its manufacturing plant in Florida in January. The FDA has not restricted the use of HeartWare devices, the company said in a statement.

  • June 3- Prosensa Holding NV said the U.S. Food and Drug Administration had outlined an accelerated regulatory approval path for its most advanced drug, aimed at treating a muscle disorder. Prosensa said it would file for European approval in the near future.

  • *Prosensa to conduct two post-approval studies. June 3- Prosensa Holding NV said the U.S. health regulator had outlined an accelerated regulatory approval path for its most advanced drug, aimed at treating a muscle disorder, sending the company's shares up 5 percent in premarket trading. Prosensa also said it would file for European approval in the near future.

  • June 3- Prosensa Holding NV said the U.S. Food and Drug Administration had outlined a regulatory path for the accelerated approval of its lead drug, sending the company's shares up 15 percent in premarket trading.

  • June 3- Prosensa Holding NV said the U.S. Food and Drug Administration had outlined a regulatory path for the accelerated approval of its lead drug. Prosensa shares were up 15 percent in premarket trading. The Dutch company said on Tuesday it planned to file an application to market the drug in the United States later this year.

  • FDA makes access to public health data easier Monday, 2 Jun 2014 | 11:25 PM ET

    June 2- U.S. Food and Drug Administration on Monday launched openFDA, a project that will make it easier for researchers, mobile application creators, web developers and the general public to access public health data collected by the regulator.

  • Ariad CEO talks Iclusig trials     Monday, 2 Jun 2014 | 12:34 PM ET

    Ariad Pharmaceuticals CEO Dr. Harvey Berger, says investors are responding to his company's better overall picture, and the progress on its leukemia drug Iclusig.

  • *Omeros shares jump 11 pct premarket. June 2- Omeros Corp said the U.S. Food and Drug Administration had approved its drug for use in cataract and lens replacement surgeries, the first drug developed by the company to get marketing clearance from the regulator.

  • UPDATE 1-FDA approves Omeros eye drug, shares rise Monday, 2 Jun 2014 | 7:57 AM ET

    June 2- Omeros Corp said the U.S. Food and Drug Administration had approved its drug for use in cataract and lens replacement surgeries, making it the company's first drug to be approved by the regulator. Omeros, whose shares were up 10 percent in premarket trading, said it plans to launch the drug, Omidria, later this year in the United States.

  • FDA approves Omeros eye drug Monday, 2 Jun 2014 | 7:15 AM ET

    June 2- Omeros Corp said the U.S. Food and Drug Administration approved its drug for use in cataract and lens replacement surgeries.

  • NEW YORK, June 2- As U.S. health regulators consider what rules to impose on electronic cigarettes, in their tally of costs and benefits they have placed a value on the lost pleasure consumers may suffer if they used the products less or not at all.

  • The FDA, which is reclassifying sun lamp products from low risk to moderate risk, said on Thursday that in future sun lamp manufacturers must seek approval before they market a new product. "We applaud the FDA for taking this important first step," said Dr.

  • The FDA said it imposed the new requirements after deciding that tanning beds and booths that use ultraviolet lamps pose a moderate risk of causing skin cancer, up from the previous classification of low-risk.

  • May 28- Acura Pharmaceuticals Inc's shares fell as much as 21 percent to a life low on Wednesday, a day after the U.S. health regulator said data on its experimental painkiller was insufficient to support its claim that the drug could not be abused by snorting.

  • *Exec says FDA issued observations on its US unit's production process. The United States is Wockhardt's biggest market and the FDA has already banned the import of generic drugs from its two plants in India, citing quality lapses in the manufacturing process.

  • Two firms recall walnuts, hummus on listeria scare Friday, 23 May 2014 | 2:38 PM ET
    Walnuts by Sherman Produce recalled due to possible health risk.

    Two companies issued voluntary recalls of hummus dips and walnuts sold at major retailers after listeria was detected in samplings of the products.

  • U.S. FDA approves Takeda drug for colitis and Crohn's Tuesday, 20 May 2014 | 4:33 PM ET

    May 20- U.S. health regulators on Tuesday approved a drug from Japan's Takeda Pharmaceutical Co Ltd to treat the chronic debilitating inflammatory diseases ulcerative colitis and Crohn's disease.

  • The FDA banned imports from Sun Pharma's Karkhadi plant in Gujarat state in March, but the reason for the ban was not clear at that time. In the warning letter dated May 7 and posted on the FDA website on Tuesday, the regulator said Sun Pharma failed to ensure laboratory records had complete data and that manufacturing staff had inadequate training and experience.