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Government Agencies FDA

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  • Sept 4- Alexion Pharmaceuticals Inc said the U.S. Food and Drug Administration would delay by three months its decision on approving a key drug the company got through the acquisition of Synageva BioPharma Corp.. The FDA, which has granted the drug "breakthrough therapy" status for LAL deficiency in infants, was expected to make its decision by Sept. 8.

  • Sept 3- AstraZeneca Plc on Thursday said the U.S. Food and Drug Administration approved a new dose of its blood thinner Brilinta intended for longer-term use in patients with a history of heart attack or a condition known as acute coronary syndrome. The FDA approved Brilinta tablets at a new 60 milligram dose that would be taken along with aspirin beyond a year...

  • Sept 3- AstraZeneca Plc said the U.S. Food and Drug Administration had approved a new dose of its blood thinner, Brilinta, for patients with a history of heart attack beyond the first year.

  • Sept 2- The U.S. Food and Drug Administration approved Tesaro Inc's treatment for chemotherapy-induced nausea and vomiting in adults, the company said on Wednesday. The drug, known chemically as rolapitant, was approved in combination with other agents to prevent delayed nausea and vomiting associated with some forms of chemotherapy, Tesaro said.

  • Sept 2- The U.S. Food and Drug Administration approved Tesaro Inc's treatment for chemotherapy-induced nausea and vomiting in adults, the company said on Wednesday. The drug, Rolapitant, was approved to be used along with other agents to prevent delayed nausea and vomiting associated with initial and repeat courses of chemotherapy, Tesaro said.

  • Since the FDA doesn't have the legal authority to pull such a substance off the shelves, the agency has been building a case against those who are marketing it in bulk in an attempt to persuade them to stop. Last summer, the FDA warned consumers to avoid pure powdered caffeine. A teaspoon of pure powdered caffeine is roughly equivalent to 28 cups of coffee, according...

  • Sept 1- The U.S. Food and Drug Administration on Tuesday issued warning letters to five distributors of pure powdered caffeine, as the federal agency stepped up efforts to curtail ingestion of the stimulant in its pure form. Earlier in 2012, the FDA issued a warning letter to Breathable Foods Inc, a company that marketed an inhalable caffeine product as'...

  • Sept 1- The U.S. Food and Drug Administration issued warning letters to five distributors of pure powdered caffeine, its latest step in curtailing ingestion of the stimulant in its pure form.

  • The deal gives Bristol-Myers access to Promedior Inc's lead experimental drug, PRM-151, which is being tested to treat two types of fibrosis. The only drug approved by the U.S. Food and Drug Administration to treat myelofibrosis is Incyte Corp's Jakafi, which raked in about $258 million in sales for the six months ended June 30. Lexington, Massachusetts- based...

  • The FDA said it had identified 33 cases of severe joint pain in patients taking a class of drugs known as DPP-4 inhibitors between Oct. 16, 2006, when the first one was approved, through Dec. 31, 2013. Five cases were reported with AstraZeneca Plc's Onglyza, two with Boehringer Ingelheim's Tradjenta, and one with Takeda Pharmaceutical's Nesina.

  • WASHINGTON, Aug 27- The U.S. Food and Drug Administration on Thursday approved Amgen Inc's Repatha drug for patients with hereditary forms of high cholesterol and those at high risk of cardiovascular disease. Last month the FDA approved a similar drug from Regeneron Pharmaceuticals Inc and Sanofi SA. The drugs are expected to generate more than $2 billion a...

  • "The FDA's job is to ensure tobacco products are not marketed in a way that leads consumers to believe cigarettes with descriptors like' additive-free' and' natural' pose fewer health risks than other cigarettes, unless the claims have been scientifically supported," Mitch Zeller, director of the FDA's tobacco products division, said in a statement.

  • FDA warns 3 tobacco product makers over labeling Thursday, 27 Aug 2015 | 1:25 PM ET

    This is the first time the FDA has pulled up companies for marketing tobacco products with "modest-risk" claims that are not backed by scientific evidence ratified by the health regulator. The Family Smoking Prevention and Tobacco Control Act of 2009 requires a company to get its modified risk tobacco product application approved by the FDA before claiming a...

  • FDA issues warning letters to "natural" tobacco makers Thursday, 27 Aug 2015 | 11:43 AM ET

    NEW YORK— The Food and Drug Administration issued warning letters to the makers of Winston, Natural Spirit and Nat Sherman cigarettes over their "additive-free" and "natural" label claims. The agency issued the warnings to ITG Brands LLC, Santa Fe Natural Tobacco Company Inc. and Sherman's 1400 Broadway N.Y.C. Ltd. The issue over the claims is that they may lead...

  • FDA lays out proposal for naming lower-cost biotech drugs Thursday, 27 Aug 2015 | 10:33 AM ET

    But representatives for the generic drug industry warned that the FDA's proposal could curb those savings by making the drugs more difficult to prescribe. For decades, they have not faced generic competition because the FDA lacked a system to approve cheaper versions until 2012. Earlier this year the agency approved the first "biosimilar."

  • Cholesterol drug wars: Amgen Thursday, 27 Aug 2015 | 6:28 AM ET
    Cholesterol drug wars: Amgen

    The FDA is expected to decide today whether to approve Amgen's cholesterol drug, Repatha, reports CNBC's Meg Tirrell.

  • Amgen files for approval of parathyroid disorder drug Tuesday, 25 Aug 2015 | 1:13 PM ET

    NEW YORK— Biotech drugmaker Amgen said Tuesday it filed for marketing approval of a drug designed to treat a symptom of chronic kidney disease. Amgen asked the Food and Drug Administration to approve its drug etelcalcetide as a treatment for secondary hyperparathyroidism, a condition that can cause fragile bones, pain, and organ damage. The Thousand Oaks,...

  • Just Mayo maker warned by FDA that 'mayo' needs eggs Tuesday, 25 Aug 2015 | 12:26 PM ET

    The FDA notes that mayonnaise must contain eggs, according to its standard of identity— and that Just Mayo does not. Hampton Creek CEO Josh Tetrick said Tuesday he had a "really good conversation" with the agency earlier in the day and that he believes it is open to "sitting down and seeing if there's common ground." The letter comes after Hampton Creek was sued last...

  • 4 Stocks, 4 trades: VRX, LLY, GPRO & LB Thursday, 20 Aug 2015 | 12:16 PM ET
    4 Stocks, 4 trades: VRX, LLY, GPRO & LB

    The FMHR traders take their positions on four stocks making news today, including Valeant buying Sprout Pharmaceuticals.

  • 'Female Viagra' sparks interest in Valeant Thursday, 20 Aug 2015 | 8:00 AM ET
    'Female Viagra' sparks interest in Valeant

    Valeant to purchase flibanserin-maker Sprout for $1 billion.