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  • FDA names potential Insys treatment an orphan drug Monday, 25 Aug 2014 | 10:17 AM ET

    A potential treatment from Insys Therapeutics Inc. for an aggressive form of brain cancer will have some marketing exclusivity if regulators eventually approve it. The Food and Drug Administration has granted an orphan drug designation to the Chandler, Arizona, drugmaker's pharmaceutical cannabidiol, or CBD.

  • Aug 25- Regado Biosciences Inc said it stopped enrollment in a late-stage trial of its lead drug after an independent safety panel raised serious concerns of allergic reactions, sending the company's shares down about 26 percent before the bell. The U.S. Food and Drug Administration also imposed a clinical hold on the trial.

  • FDA clears Eliquis for new use against blood clots Thursday, 21 Aug 2014 | 3:10 PM ET

    WASHINGTON— Bristol-Myers Squibb and Pfizer said Thursday that federal regulators have expanded approval of their blood thinner Eliquis to treat two types of dangerous blood clots. The Food and Drug Administration cleared the drug for patients suffering from or at risk of deep vein thrombosis and pulmonary embolism.

  • FDA approves new drug for rare genetic disease Tuesday, 19 Aug 2014 | 6:00 PM ET

    Cerdelga is from Genzyme, the specialty drugmaker that introduced the first drug for Gaucher's disease 20 years ago. The oral treatment could serve as an alternative to Genzyme's best-selling drug Cerezyme, which is given intravenously. Genzyme says it will soon release pricing for its new drug.

  • FDA approves Biogen's MS drug Plegridy Friday, 15 Aug 2014 | 7:27 PM ET

    CAMBRIDGE, Mass.— Biogen Idec says that federal regulators have approved the specialty drugmaker's new treatment for people with relapsing forms of multiple sclerosis.

  • FDA clears Avastin for late-stage cervical cancer Friday, 15 Aug 2014 | 10:44 AM ET

    WASHINGTON— The Food and Drug Administration has approved Genentech's Avastin for a new use against late-stage cervical cancer, the seventh indication for the blockbuster biotech drug. The FDA approved the drug late Thursday for women with cervical cancer that is persistent, recurrent or has spread to other parts of the body.

  • Aug 15- Acura Pharmaceuticals Inc said the U.S. Food and Drug Administration indicated that the company may have to conduct an additional study to determine the abuse-deterrent capability of its experimental painkiller treatment. The FDA in May said data was insufficient to support the company's claim that the drug could not be abused by snorting.

  • Aug 8- Shares of Canada's Tekmira Pharmaceutical Corp jumped as much as 25 percent in early trading on Friday, after a regulator cleared its experimental Ebola drug for 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.

  • 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.