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  • May 7- Amarin Corp Plc filed suit against the U.S. Food and Drug Administration on Thursday for restricting its right to promote its fish oil drug Vascepa for an unapproved, or off-label, use. The suit, filed on Thursday in U.S. District Court for the Southern District of New York, argues that the FDA's ban violates Amarin's right to free speech under the First...

  • WASHINGTON, May 6- The U.S. Food and Drug Administration will hold a public meeting this summer to address drug company concern that restrictions on what they can say about off-label use of drugs violate their first amendment right to free speech. Efforts by drug companies to change the rules gained steam after a 2012 decision from the Second Circuit Court of...

  • May 4- AcelRx Pharmaceuticals Inc said a division of the U.S. Food and Drug Administration had rejected the company's request for a meeting to discuss the need for an additional trial of its pain drug device, Zalviso. The company's shares fell about 32 percent to $2.85 in after-market trading on Monday after the FDA also restated its view that the additional...

  • April 30- The U.S. Food and Drug Administration on Thursday approved The Medicines Co's dry powder blood-clotting agent for use in hospital settings, a month after the treatment received approval in Europe. The approval comes at a time Medicines Co is facing a drop in sales of its lead product, Angiomax anticoagulant injection, which accounted for over 80...

  • FDA approves Medicines Co's blood clotting agent Thursday, 30 Apr 2015 | 5:47 PM ET

    April 30- The U. S Food and Drug Administration approved the Medicines Co's dry powder blood clotting agent for use in hospital settings, a month after the treatment received approval in Europe. The treatment, Raplixa, is a combination of two human plasma-derived blood-clotting proteins, fibrinogen and thrombin. Raplixa is used to control bleeding during...

  • Biotech bust may be sending message about stocks Thursday, 30 Apr 2015 | 5:03 PM ET
    Traders work on the floor of the New York Stock Exchange.

    Traders are watching the iShares Nasdaq Biotechnology ETF for clues on whether a deeper stock market decline is on the horizon.

  • Since the review of healthcare antiseptics in the 1970' s, things have changed, the FDA noted, alluding to a shift in frequency of use, a hospital's infection control practices, technology and safety standards. The regulator is looking to play catch up with the scientific community after an independent panel of experts to the FDA raised similar concerns last year.

  • FDA seeks more data on antiseptic ingredients Thursday, 30 Apr 2015 | 10:49 AM ET

    Alcohol and iodines are the most common active ingredients in such antiseptics, the FDA said, adding that home-use antiseptics such as antibacterial soap and hand sanitizers are not part of this evaluation. Accordingly, the FDA is requesting more data on absorption, potential hormonal effects and bacterial resistance of antiseptics under the...

  • April 29- Amgen Inc's skin cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval, an independent advisory panel to the U.S. Food and Drug Administration said on Wednesday. Amgen said on Wednesday that T-Vec was more effective in melanoma patients whose cancer had not spread to internal organs.

  • April 29- Amgen Inc's skin cancer immunotherapy showed enough efficacy in the treatment of melanoma to be given marketing approval, an independent advisory panel to the U.S. Food and Drug Administration said on Wednesday. The panel voted 22-1 supporting an approval for the therapy, talimogene laherparepvec or "T-Vec", an engineered virus that kills cancer...

  • Tips to overcome business challenges Wednesday, 29 Apr 2015 | 1:41 PM ET
    Business woman hurdle

    Three CEOs tell how they overcame a challenge by listening, being resourceful and communication, reports USA Today.

  • April 29- The U.S. Food and Drug Administration said on Wednesday it approved an injection for "double chin" reduction, developed by Kythera Biopharmaceuticals Inc.. Submental, or below the chin, liposuction costs between $2,700 and $5,175, according to the American Society for Dermatologic Surgery. Last year, Kythera regained the rights to market the drug...

  • The FDA said it considered Velocity adulterated because there is not enough information to provide reasonable assurance that DMBA is safe. The FDA actions come amid pressure from lawmakers and a Harvard University academic, Dr. "Rather than waiting until heart attacks, strokes or deaths are definitely linked to this new designer stimulant, the FDA has now made...

  • April 27- Medtronic Plc has agreed to resolve U.S. regulators' allegations it violated quality standards for making its SynchroMed implantable infusion pump, which delivers medications to cancer patients and others with chronic pain. The agreement includes Medtronic Chief Executive Omar Ishrak and Senior Vice President Thomas Tefft.

  • Biotechs stick it to stocks Monday, 27 Apr 2015 | 4:30 PM ET
    Medical injection

    Biotech is getting roughed up, after leading the market's gains this year.

  • April 27- Medical device maker Medtronic Plc said it reached a settlement agreement with the U.S. Food and Drug Administration over one of the company's drug delivery systems. The consent decree places some restrictions on the company and outlines the steps it must take to address the FDA's expectations, the company said on Monday. The agreement does not...

  • *Amgen's fall drags downs biotech stocks. Amgen shares dropped 3.2 percent to $162.53 after U.S. Food and Drug Administration staff reviewers said Amgen's skin cancer immunotherapy cannot be considered for an accelerated review at this time, citing concerns over the design and results of a key study. The healthcare sector is being dragged down by reports on...

  • *FDA cites concerns over late-stage study design, results. April 27- U.S. Food and Drug Administration staff reviewers said an accelerated review of drugmaker Amgen Inc's skin cancer immunotherapy cannot be considered at this time, citing concerns over the design and results of a key study. T-Vec represents a new class of agent for the treatment of metastatic...

  • April 27- The U.S. Food and Drug Administration should not consider an accelerated review of Amgen Inc's marketing application for its skin cancer vaccine, FDA staff reviewers concluded in documents released on Monday, citing concerns over the design and results of a key study. The review comes two days before a panel of FDA advisers votes on whether the...

  • April 27- The U.S. Food and Drug Administration should not consider an accelerated review for drugmaker Amgen Inc's marketing application for its skin cancer vaccine, FDA staff reviewers concluded in documents released on Monday. The review comes two days before a panel of FDA advisers votes on whether the treatment, a cancer-killing virus called talimogene...