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  • July 8- Amgen Inc's version of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, appears similar in potency and safety to the original product, U.S. Food and Drug Administration staff members said on Friday. In two large Amgen studies, the Thousand Oaks, California- based company said it showed similar effectiveness to Humira.

  • July 8- Amgen Inc's version of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, appears similar in potency and safety to the original product, U.S. Food and Drug Administration staff members said on Friday. In two large Amgen-sponsored studies, the Thousand Oaks, California- based company said it showed similar effectiveness to Humira.

  • July 8- Amgen Inc's biosimilar form of AbbVie Inc's Humira arthritis drug, the world's top-selling medicine, is similarly potent and safe as the original product, according to a preliminary review by staff members of the U.S. Food and Drug Administration. The assessment precedes an all-day meeting on Tuesday of an independent panel of medical advisers who will...

  • The U.S. Food and Drug Administration halted the trial after a patient died in May and two more died last week, Juno Chief Executive Officer Hans Bishop told reporters on a conference call. Seattle- based Juno said the deaths occurred after the chemotherapy agent fludarabine was added to the trial program. The company said it has proposed to the U.S. Food and Drug...

  • Shares of Juno fell 30 percent to $28.50 in after-hours trading on the Nasdaq after they closed at $40.82. A third trial patient died in May, Juno Chief Executive Officer Hans Bishop said during a conference call. The company said it has proposed to the U.S. Food and Drug Administration that the trial be continued using JCAR015 with just cyclophosphamide as a "...

  • Juno tanks after hours

    CNBC's Meg Tirrell reports the latest on the FDA putting Juno's cancer clinical trial on hold. The "Fast Money" traders weigh in on the biotech sector.

  • Hand sanitizers

    The FDA says makers of sanitizer products need to show they're safe and work as well as people believe they do, reported NBC News.

  • The group had sued the FDA, claiming the agency failed to regulate toxic chemicals found in antimicrobial soap and other personal care products. NRDC's senior attorney Mae Wu said the FDA action was "long overdue". "We believe that the FDA has a wealth of data on hand sanitizers in their possession to judge them as generally recognized as safe and effective," the...

  • June 29- The U.S. Food and Drug Administration said it is requesting additional data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs, including hand sanitizers, that are sold over-the-counter. The request for more data is intended to help the agency ensure that regular use of these products does...

  • June 29- The U.S. Food and Drug Administration said it is requesting additional data to support the safety and effectiveness of certain active ingredients used in topical consumer antiseptic rubs, including hand sanitizers, that are sold over-the-counter. The request for more data is intended to help the agency ensure that regular use of these products does...

  • June 28- Eli Lilly& Co and Boehringer Ingelheim should be allowed to claim that their diabetes drug Jardiance cuts the risk of cardiovascular death, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically does so. When the FDA approved Jardiance it asked...

  • June 28- Eli Lilly& Co and Boehringer Ingelheim should be allowed to claim that their diabetes drug Jardiance cuts the risk of cardiovascular death, an advisory panel to the U.S. Food and Drug Administration concluded on Tuesday. The FDA is not obliged to follow the advice of its advisory committees but typically does so. Jardiance, also known as empagliflozin, was...

  • Tablets of AstraZeneca Plc's cholesterol drug Crestor.

    AstraZeneca is trying to fend off generic competition to Crestor by getting it approved to treat a rare disease, NYT reported.

  • Gilead said in a separate statement that it priced the drug at $74,760 for a 12- week regimen. For those with moderate to severe cirrhosis, Epclusa must be taken with the older drug ribavirin, the Food and Drug Administration said. "This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," Edward Cox, director of...

  • CNBC's Meg Tirrell reports on moves in pharmaceutical stocks including Gilead rising on FDA approval for its new combo hepatitis C pill.

  • For those with moderate to severe cirrhosis, Epclusa must be taken with the older drug ribavirin, the Food and Drug Administration said. "This approval offers a management and treatment option for a wider scope of patients with chronic hepatitis C," Edward Cox, director of the FDA's Office of Antimicrobial Products, said in a statement. In other parts of the world,...

  • June 28- The U.S. Food and Drug Administration approved Gilead Sciences Inc's drug for treating chronic hepatitis C virus infection. The drug, Epclusa, is approved for use in combination with ribavirin. Gilead shares were up 4 pct at $81.03 in morning trading on the Nasdaq.

  • *EMA, FDA reviewing new treatment for two forms of MS. The U.S. Food and Drug Administration and the European Medicines Agency accepted marketing applications for Roche's Ocrevus medicine, for both the relapsing-remitting and primary-progressive forms of MS, the company said in a statement. With FDA fast-track review, Roche said U.S. approval for Ocrevus now...

  • June 27- Regulus Therapeutics Inc said the U.S. Food and Drug Administration placed on clinical hold the company's drug to treat chronic hepatitis C virus infection, sending its shares plunging 60 percent in extended trading. The FDA initiated the clinical hold on the drug, RG-101, after Regulus reported a second serious adverse event of jaundice, the company...

  • GW Phamarceuticals

    The drug, a treatment option for people with Lennox-Gastaut syndrome, has been shown to reduce the number of monthly seizures in some patients.