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  • Impax Labs shares slump after FDA inspection Tuesday, 29 Jul 2014 | 3:38 PM ET

    NEW YORK— Shares of Impax Labs sank Tuesday after an FDA inspection uncovered potential problems at a facility where the company will make its experimental Parkinson's disease drug Rytary. Impax has been unable to get marketing approval for Rytary because of problems stemming from FDA inspections.

  • *FDA lists 10 violations at Taiwan plant. July 29- Impax Laboratories Inc said the U.S. Food and Drug Administration raised concerns about the company's factory in Taiwan, casting in doubt the future of its Parkinson's drug, rytary.

  • July 29- Impax Laboratories Inc said the U.S. Food and Drug Administration issued certain observations regarding violations in the company's manufacturing plant in Taiwan. Shares of Impax, which makes generics and specialty drugs to treat central nervous system disorders, fell about 17 percent to $23.15 premarket on Tuesday.

  • U.S. FDA raises concerns about Impax's Taiwanese plant Tuesday, 29 Jul 2014 | 8:18 AM ET

    July 29- Impax Laboratories Inc said the U.S. Food and Drug Administration issued "certain observations" after an inspection of the company's manufacturing plant in Taiwan. "The FDA did not provide any status or classification to these observations," the company said. It closed at $28.03 on Monday.

  • Analysts, who were surprised by the decision, said the issues cited by the FDA were "rather mild" and expected Zalviso to eventually receive approval. The FDA in its complete response letter sought more data to ensure proper use of the device but did not ask for additional human clinical trials.

  • July 28- Shares of AcelRx Pharmaceuticals Inc plunged nearly 28 percent in premarket trading, after the U.S. Food and Drug Administration rejected its pain drug device, Zalviso, late on Friday. AcelRx said it would resubmit its marketing application for Zalviso by the end of the year, pending further discussions with the FDA.

  • 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.