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Government Agencies FDA


  • 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."

  • 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.

  • WASHINGTON— Valeant Pharmaceuticals will pay about $1 billion in cash to buy Sprout Pharmaceuticals, the maker of the first prescription drug intended to boost sexual desire in women. Founded by a husband-and-wife team, Sprout has aggressively pushed the case for their product for years, arguing in dozens of interviews that the Food and Drug Administration...

  • '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.

  • Samsung entering into U.S. exchanges Thursday, 20 Aug 2015 | 8:00 AM ET
    Samsung entering into U.S. exchanges

    Samsung is planning its first U.S. stock listing.

  • Aug 20- Canada's Valeant Pharmaceuticals International Inc said it would buy privately owned Sprout Pharmaceuticals, whose drug became the first approved treatment this week for low sexual desire in women, for about $1 billion plus milestone payments. Addyi was approved on Tuesday by the U.S. Food and Drug Administration for pre-menopausal women, after...

  • Valeant to buy female libido drugmaker for $1B Thursday, 20 Aug 2015 | 6:03 AM ET
    Michael Pearson, chairman and CEO of Valeant, has reportedly presided over more than 100 deals since taking over as boss in 20018.

    Valeant is buying the company that just won approval to sell "female Viagra."

  • Aug 20- Canada's Valeant Pharmaceuticals International Inc is nearing a deal to pay $1 billion for Sprout Pharmaceuticals, the company that just won approval to sell the first drug that aims to boost a woman's libido, the Wall Street Journal reported. The U.S. Food and Drug Administration late on Tuesday approved Sprout's drug for pre-menopausal women.

  • Aug 19- Medical device maker Boston Scientific Inc said the U.S. Food and Drug Administration approved its device to prevent the block of arteries in the legs which leads to peripheral artery disease.

  • AbbVie buys special review voucher for $350 mln Wednesday, 19 Aug 2015 | 10:41 AM ET

    Aug 19- AbbVie Inc has bought a priority review voucher from United Therapeutics Corp for $350 million that will allow it to accelerate the review process for one of its drugs. United Therapeutics received a rare pediatric disease priority review voucher in March after its drug, Unituxin, was approved by the U.S. Food and Drug Administration to treat...

  • 'Female Viagra' hits the markets this fall Wednesday, 19 Aug 2015 | 10:00 AM ET
    'Female Viagra' hits the markets this fall

    The FDA approved the first prescription drug for enhancing female libido.

  • 'Female Viagra' may only help some: Doctor Wednesday, 19 Aug 2015 | 12:57 AM ET
    A tablet of flibanserin sits on a brochure for Sprout Pharmaceuticals in the company's Raleigh, N.C., headquarters.

    A so-called female Viagra may have received FDA approval, but the patients it may actually help could be limited, Dr. Lisa Dabney says.

  • FDA approves first pill aimed at boosting female libido Wednesday, 19 Aug 2015 | 12:05 AM ET

    WASHINGTON— The Food and Drug Administration has approved the first prescription drug designed to boost sexual desire in women, a milestone long sought by a pharmaceutical industry eager to replicate the blockbuster success of impotence drugs for men. Under an FDA- imposed safety plan, doctors will only be able to prescribe Addyi after completing an online...