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  • July 2- Vertex Pharmaceuticals Inc's unique combination therapy for a rare lung disorder was given the green light by U.S. health regulators, extending the company's reach to the most common form of genetic mutation responsible for cystic fibrosis. Orkambi, a combination of Vertex's approved drug Kalydeco and a new compound called lumacaftor, is intended for...

  • FDA clears drug for leading form of cystic fibrosis Thursday, 2 Jul 2015 | 12:22 PM ET

    WASHINGTON— Federal health officials have approved a new combination drug for the most common form of cystic fibrosis, the debilitating inherited disease that causes internal mucus buildup, lung infections and early death. But it will come at a steep price— more than $250,000 for a year's treatment. The Food and Drug Administration cleared the twice-a-day...

  • July 2- Vertex Pharmaceuticals Inc's combination therapy for a rare lung disorder was approved by U.S. health regulators, extending the company's reach to now treat the most common form of genetic mutation responsible for cystic fibrosis. Orkambi, a combination of Vertex's approved drug Kalydeco and a new compound called lumacaftor, is intended for patients...

  • July 1- Bayer Healthcare said on Wednesday the U.S. Food and Drug Administration approved using transvaginal ultrasound as an alternate test to confirm if the company's Essure permanent birth control device has been placed properly. But since its approval in 2002, women using the device have sent the FDA more than 5,000 complaints, ranging from pain and...

  • FDA cracks down on unapproved ear drops Wednesday, 1 Jul 2015 | 10:39 AM ET

    Because the products are not overseen by FDA regulators they could be contaminated or manufactured incorrectly. The agency notes that there are numerous FDA- approved ear drops, so "little or no impact on patients" is expected from removing the products from the market. Companies that want federal approval for their drugs must submit an FDA application for...

  • June 30- The U.S. Food and Drug Administration said it is seeking additional data and comments on liquid nicotine as it considers warning the public about the dangers of its exposure amid a rise in electronic cigarette use. More Americans are using e-cigarettes and other vaporizing devices than a year ago, a Reuters/ Ipsos poll showed in June.

  • WASHINGTON— The makers of the potent painkiller OxyContin have pulled out of a federal meeting to review the company's harder-to-abuse version of the much-debated drug. As a result, the company has withdrawn its application that was slated to be reviewed before a Food and Drug Administration committee next week. FDA meetings are typically planned months in...

  • FDA weighs new restrictions on liquid nicotine products Tuesday, 30 Jun 2015 | 10:54 AM ET

    The Food and Drug Administration said Tuesday it is responding to an uptick in nicotine poisonings reported by emergency rooms and poison centers nationwide, many involving infants and children. Under a 2009 law, the FDA gained authority to regulate some aspects of cigarettes and other traditional tobacco products. A year ago, the FDA released a proposal...

  • In their June 25 lawsuit, Yale University's Global Health Justice Partnership and the Treatment Action Group, an AIDS non-profit, said doctors and patients deserve more information about the "enormously costly" drugs Harvoni and Sovaldi to make informed decisions about whether to use them. The plaintiffs said Gilead ignored its request for the trial data,...

  • June 26- Animal health drugmaker Aratana Therapeutics Inc said its experimental appetite-stimulating drug was found effective in dogs in a pivotal study. The company said it plans to submit the results to the U.S. Food and Drug Administration as it seeks marketing approval, and expects to start commercializing the drug in 2016.. The Kansas City- based...

  • FDA reviewing safety of Essure birth control implant Thursday, 25 Jun 2015 | 10:26 AM ET

    The Food and Drug Administration says those problems have not been established in studies of the device and are not listed on the product label. The device was first approved by the FDA in 2002.. Despite those findings, the FDA says it has continued to receive reports of complications from patients.

  • 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...

  • 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.

  • 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...