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    Opko Health rose more than 5 percent after the U.S. Food and Drug Administration approved the drug Rayaldee.

  • Emergent BioSolutions Vice President Dino Muzzin holds a product sample of BioThrax, the only FDA-licensed vaccine available for pre-exposure protection against anthrax infection.

    Emergent BioSolutions moved closer to FDA approval for a large-scale facility for making BioThrax, a vaccine for protection against anthrax.

  • The U.S. Food and Drug Administration granted emergency use authorization for the company's Aptima test to detect Zika virus in human serum and plasma specimens. Aptima is the third commercial test to be granted emergency use authorization by the FDA. Focus Diagnostics and Germany's altona Diagnostics GmbH were also given emergency use authorization.

  • *U.S. says Sanjay Valvani got tips leaked from within FDA. NEW YORK, June 15- A Manhattan hedge fund manager was charged on Wednesday with trading on confidential tips about drug approvals, in one of the biggest insider trading cases since a 2014 court ruling made it harder for U.S. prosecutors to pursue them. Attorney Preet Bharara in Manhattan accused Sanjay...

  • Whole Foods sours

    The "Fast Money" traders discuss the Whole Foods trade after the grocery chain gets a warning letter from the FDA.

  • WHO: Very low risk of international spread of Zika from Olympics

    CNBC's Meg Tirrell reports on the World Health Organization saying that there is very low risk of further interantional spread of the Zika virus during the Olympic Games, as well as on the FDA approval of a new obesity device.

  • The AspireAssist device uses a surgically-placed tube to drain a portion of the stomach contents after every meal.

    A new device that drains a portion of a person's stomach contents after every meal, has just won approval from the U.S. Food and Drug Administration.

  • Long lines of people wait at the OneBlood Donation Center to donate blood for the injured victims of the Pulse nightclub shooting on June 12, 2016 in Orlando, Florida.

    Gay Men's Health Crisis CEO Kelsey Louie criticizes the Food and Drug Administration's continued ban on gay blood donations.

  • The Department of Health and Human Services' Office of Inspector General reviewed 30 recalls that occurred between 2012 and 2015, including two in which companies did not recall all affected items until 165 days and 81 days after the FDA became aware of tainted foods. "FDA does not have adequate policies and procedures to ensure that firms take prompt and...

  • The FDA said its Office of Criminal Investigations, Office of Regulatory Affairs, and Center for Drug Evaluation and Research were part of the enforcement action, which ran from May 31 to June 7. The FDA and the U.S. Customs and Border Protection inspected international mail facilities, and then sent formal complaints to domain registrars requesting the...

  • June 7- Zimmer Biomet Holdings Inc agreed to buy fellow medical device maker LDR Holding Corp for about $1 billion deal to expand in the market for treating spine disorders. The $37 per share offer represents a premium of about 64 percent to LDR's Monday close. The company's biggest product is Mobi-C CDR, the first and only U.S. Food and Drug Administration...

  • Laura Niklason, founder of Humacyte

    Humacyte claims to have created the first bioengineered blood vessel, which could reduce infection risk and tissue rejection after surgery.

  • June 6- Sarepta Therapeutics Inc said the U.S. Food and Drug Administration has requested for additional data for its muscle-wasting treatment as the agency decides whether to approve the drug or not. The FDA deferred a highly anticipated decision on whether to approve Sarepta's drug, eteplirsen, last month, after an advisory panel determined that the...

  • June 6- Sarepta Therapeutics Inc said the U.S. Food and Drug Administration has requested for additional data for its muscle-wasting treatment as the agency decides whether to approve the drug or not. The FDA deferred a highly anticipated decision on whether to approve Sarepta's drug, eteplirsen, last month, after an advisory panel determined that the...

  • NYSE Closing, after hours

    Check out the companies making headlines after the bell Monday: Sarepta, Alexion, Whole Foods and more.

  • Ariad confident on cancer drug data

    Ariad Pharmaceuticals President and CEO Paris Panayiotopoulos, discusses patient response to cancer treatment Brigatinib.

  • June 6- A long-acting opioid painkiller being developed by Pfizer Inc has the potential to deter abuse but can be manipulated, a preliminary review by the U.S. Food and Drug Administration showed. FDA reviewers said in a report published on Monday that oxycodone could be selectively extracted from intact pellets by a number of straightforward techniques and...

  • June 6- An experimental, long-acting opioid painkiller from Pfizer Inc showed potential to deter abuse but can be manipulated, according to a preliminary review by the U.S. Food and Drug Administration. The review was published on the agency's website on Monday and comes ahead of a June 8 meeting of outside experts, who will discuss the drug and recommend whether...

  • June 6- The U.S. Food and Drug Administration approved Allergan Plc's treatment for high blood pressure or hypertension, the company said on Monday. The therapy, Byvalson, is a fixed-dose combination of two FDA- approved blood pressure lowering agents, Nebivolol and Valsartan. The two drugs fight hypertension using different mechanisms of action and are...

  • June 6- Adamis Pharmaceuticals Corp said on Monday the U.S. Food and Drug Administration rejected its emergency treatment for acute anaphylaxis, a severe allergic reaction, for the second time. The company said it expects to complete the additional testing and submit the data to the FDA by the second half of 2016.. The FDA had rejected the original marketing...