GO
Loading...

FDA

More

  • FDA reviewing what could be first biosimilar drug Thursday, 24 Jul 2014 | 3:41 PM ET

    Nearly five years after Congress passed a law enabling future approval of biosimilars, for the first time the FDA has accepted an application to sell a similar, but not identical, version of a biologic drug.

  • Reversing a lower court ruling, the 2nd U.S. Circuit Court of Appeals in New York said the FDA was empowered to reject two citizen challenges to its policy, which discourages but does not ban the use of penicillin and some tetracyclines in feed for chickens, cows and pigs, even if they are not sick.

  • Reversing a lower court ruling, the 2nd U.S. Circuit Court of Appeals in New York said the FDA was empowered to reject two citizen challenges to its policy, which discourages but does not ban the use of penicillin and some tetracyclines in feed for chickens, cows and pigs, even if they are not sick.

  • FDA approves new painkiller from OxyContin maker Wednesday, 23 Jul 2014 | 5:45 PM ET

    FDA regulators approved the drug for daily, round-the-clock pain that does not respond to other medications. The FDA notes that Targiniq can still be abused by simply swallowing the tablets, the most frequent method of painkiller abuse. The FDA has been under intense public pressure to combat the national epidemic of prescription opioid abuse.

  • FDA warns of compounded drug recall by Texas firm Wednesday, 23 Jul 2014 | 3:25 PM ET

    WASHINGTON— The Food and Drug Administration warned doctors Wednesday not to use compounded drugs from a Texas specialty pharmacy due to potential risks of contamination. The agency says FDA inspectors recently uncovered unsanitary conditions at Unique Pharmaceuticals' plant in Temple, Texas.

  • July 23- The U.S. Food and Drug Administration said on Wednesday it has approved Gilead Sciences Inc's Zydelig, a drug to treat three types of blood cancer. The FDA approved the use of Zydelig in combination with Roche AG's Rituxan for patients with relapsed chronic lymphocytic leukemia.

  • FDA approves Gilead Sciences drug for 3 cancers Wednesday, 23 Jul 2014 | 12:57 PM ET

    WASHINGTON— The Food and Drug Administration on Wednesday approved a new cancer drug from Gilead Sciences Inc. to treat three types of blood cancer. The FDA has approved three other drugs for the disease in the last year: Roche's Gazyva, Janssen Pharmaceutical's Imbruvica and GlaxoSmithKline's Arzerra.

  • U.S. FDA approves Gilead's blood cancer drug Zydelig Wednesday, 23 Jul 2014 | 12:05 PM ET

    July 23- The U.S. Food and Drug Administration has approved Gilead Inc's drug Zydelig to treat three types of blood cancer, the agency said on Wednesday. The FDA approved it for use in combination with Roche AG's Rituxan for patients with relapsed chronic lymphocytic leukemia.

  • Protections set up by the U.S. Food and Drug Administration called "risk evaluation and mitigation strategies", which can curb distribution of dangerous medicines, have been used to prevent generic drugmakers from getting the drugs in order to test their own versions, which is required to win FDA approval, the report from the Generic Pharmaceutical Association said.

  • July 23- Eagle Pharmaceuticals Inc said the U.S. Food and Drug Administration approved its drug to treat an inherited life-threatening condition called malignant hyperthermia. Eagle Pharmaceuticals is also testing Ryanodex for use in exertional heatstroke.

  • California firm issues nationwide fruit recall Tuesday, 22 Jul 2014 | 8:54 AM ET

    Wawona Packing Co. President Brent Smittcamp said in a statement that he is not aware of any illnesses caused by the fruit, and the voluntary recall was announced after consulting with the U.S. Food and Drug Administration.

  • U.S. District Court Judge Richard Leon ordered the FDA reconstitute the committee and barred the agency from using the panel's findings, which said removing menthol cigarettes from the market would benefit public health.

  • U.S. District Court Judge Richard Leon ordered the FDA reconstitute the committee and barred the agency from using the panel's findings, which said removing menthol cigarettes from the market would benefit public health.

  • Judge: FDA can't use tobacco panel menthol report Monday, 21 Jul 2014 | 6:25 PM ET

    U.S. District Court Judge Richard Leon in Washington ordered the FDA on Monday to reconstitute the tobacco panel and barred the agency from using its older report on menthol cigarettes.

  • NEW YORK, July 16- A proposal to overhaul nutrition labels on packaged foods sold in the United States does not go far enough to influence consumer choices and reduce obesity, a former U.S.

  • Health officials: Food label changes not enough Wednesday, 16 Jul 2014 | 5:00 PM ET

    The Food and Drug Administration is working on a label overhaul and has proposed two different versions. Writing separately in The New England Journal of Medicine on Wednesday, former FDA Commissioner David Kessler and former Centers for Disease Control and Prevention official William H. Dietz both say the FDA doesn't go far enough.

  • WASHINGTON, July 11- Last year the U.S. Food and Drug Administration recommended that millions of dollars in research grants be awarded to scientists serving on its tobacco advisory committee, even as it rejected several projects deemed by a National Institutes of Health panel to have greater scientific merit, according to confidential scores reviewed by Reuters.

  • FDA weighs cancer risk of fibroid removal devices Friday, 11 Jul 2014 | 12:27 PM ET

    The panel of Food and Drug Administration experts also said Friday that women who do undergo the procedure should sign a written consent form stating they understand the serious risks of laparoscopic power morcellation, in which electronic tools are used to grind tissue and remove it through a small incision in the abdomen.

  • July 8- Anacor Pharmaceutical Inc said the U.S. Food and Drug Administration approved its treatment for a fungal infection of the toenail. The topical solution, Kerydin, is expected to be launched as early as the end of the quarter in the United States, the company said on Tuesday.

  • In preparatory documents posted on the agency's website on Tuesday, FDA reviewers said laparoscopic power morcellator devices, which are used to treat uterine fibroids, allow for less invasive surgeries, shorter recovery time and fewer wound site infections.