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  • Aug 7- Tekmira Pharmaceutical Corp said on Thursday that the U.S. Food and Drug Administration had modified its clinical hold status on Tekmira's experimental Ebola treatment to enable its potential use in humans infected with the virus.

  • Aug 7- Tekmira Pharmaceutical Corp said on Thursday that the U.S. Food and Drug Administration had modified its clinical hold status on Tekmira's experimental Ebola treatment to enable its potential use in humans infected with the virus.

  • *Cuts top end of FY earnings forecast to $3.45/ shr from $3.60/ shr. Aug 7- Mylan Inc shaved the top end of its full-year revenue and earnings forecasts, citing delays in approval from the U.S. Food and Drug Administration for key generic drugs that it plans to launch this year.

  • Clearing FDA hurdles     Thursday, 7 Aug 2014 | 6:51 AM ET

    Scott Gottlieb, M.D., American Enterprise Institute, explains why he thinks excessive FDA regulations are stalling innovation in medical technology.

  • Mylan narrows full-year revenue, profit forecast Thursday, 7 Aug 2014 | 6:48 AM ET

    Aug 7- Generic drug maker Mylan Inc narrowed its full-year revenue and earnings forecast, citing delays in U.S. Food and Drug Administration approval of key products. The company narrowed its revenue forecast range to $7.8 billion- $8 billion from $7.8 billion- $8.2 billion.

  • Gaining access to experimental drugs     Tuesday, 5 Aug 2014 | 7:44 AM ET

    Scott Gottlieb, M.D., American Enterprise Institute, and Jeff Allen, Friends of Cancer Research executive director, discuss the FDA's drug approval process and the need in some cases to allow access to experimental therapies.

  • Why dying kids can't get the drugs they need Tuesday, 5 Aug 2014 | 7:33 AM ET
    Nathalie Traller back in the clinic.

    Terminally ill patients are increasingly seeking access experimental drugs outside clinical trials, but drug companies often decline these requests. A look at why.

  • A senior official within FDA told Reuters the agency would consider proposals for providing treatments under special emergency new drug applications, if the benefits of the treatment outweighed the potential safety risks. The hold prompted a North Carolina physician with family members in West Africa to say enough.

  • A senior official within FDA told Reuters the agency would consider proposals for providing treatments under special emergency new drug applications, if the benefits of the treatment outweighed the potential safety risks. The hold prompted a North Carolina physician with family members in West Africa to say enough.

  • The FDA, which had raised concerns that some patients developed antibodies to one component of the treatment, is not obliged to follow the advice of its advisory panels but typically does so. The FDA had asked whether certain subgroups of patients, such as pregnant women, should be excluded.

  • Ebola serum arrives in Liberia, only enough for one Thursday, 31 Jul 2014 | 2:19 PM ET
    A pharmacist searches for drugs in a pharmacy in Lagos, Nigeria, July 26, 2014.

    A dose of experimental serum arrived in Liberia to be tried on a U.S. charity worker—but there was only enough for one of the two infected workers, NBC.

  • *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.

  • Big lobbying dollars flow in engineered food fight Tuesday, 29 Jul 2014 | 4:29 AM ET
    A researcher takes tissue samples from genetically modified corn plants.

    The way consumers would be informed when their food has been genetically engineered is being battled in Congress and among advocacy groups.

  • 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.

  • 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.

  • 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.