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  • 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...

  • 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...

  • April 23- Boehringer Ingelheim Pharmaceuticals Inc said its drug to reverse blood thinning was granted a priority review status by the U.S. Food and Drug Administration, accelerating the regulatory process by four months.

  • April 23- Boehringer Ingelheim Pharmaceuticals Inc said its emergency blood clotting agent was granted a priority review status by the U.S. Food and Drug Administration, accelerating the regulatory process by four months.

  • One start-up's quest to prevent breast cancer Tuesday, 21 Apr 2015 | 10:31 AM ET
    Mary-Claire King, the University of Washington geneticist whose work led to the discovery of the BRCA1 gene

    Color Genomics plans to charge only $249 for an analysis of cancer-risk genes. New York Times reports.

  • Bullish case for bird flu?   Tuesday, 21 Apr 2015 | 7:21 AM ET
    Bullish case for bird flu?

    Farha Aslam, Stephens food analyst, provides perspective on the current outbreak of bird flu and why it could present investors with a buying opportunity.

  • UPDATE 1-FDA approves AcuFocus' corneal implant Friday, 17 Apr 2015 | 6:37 PM ET

    April 17- The U.S. Food and Drug Administration approved AcuFocus Inc's corneal implant to improve vision in patients with presbyopia, an age-related eye disorder. The device, KAMRA inlay, is the first implantable device to correct vision in patients who have not had cataract surgery, the FDA said in a statement on Friday. The FDA, however, warned that the device...

  • FDA approves AcuFocus' corneal implant Friday, 17 Apr 2015 | 5:49 PM ET

    April 17- The U.S. Food and Drug Administration approved AcuFocus Inc's corneal implant to improve vision in patients with presbyopia, an age-related eye disorder. The device, KAMRA inlay, is the first implantable device to correct vision in patients who have not had cataract surgery, the FDA said in a statement on Friday. Presbyopia is a condition associated...

  • The copied 20 mg version of the blockbuster drug, submitted by Sandoz, a unit of Swiss drugmaker Novartis AG, can be labeled "substitutable" for Copaxone, meaning that prescriptions for the brand-name drug can be automatically switched to the generic. The generic drug, called Glatopa, was developed collaboratively by Novartis and Momenta Pharmaceuticals Inc...