Food and Drug Administration
Food and Drug Administration Newswire

Food and Drug Administration Newswire

Comprehensive Real-Time News Feed for Food and Drug Administration.

Results 1 - 20 of 39,487 in Food and Drug Administration

  1. Small Cap Movers: Good week for biotech firms Bioventix and Motif...Read the original story w/Photo

    3 min ago | This Is Money

    Individual investors, apparently emboldened by changes to ISA rules and low returns on savings, now own nearly a third of all shares listed on London's AIM market. Figures from the Office of National Statistics have revealed that 30.6 per cent of AIM shares were held by individuals in 2014, whereas private investors accounted for just 9.5 per cent of FTSE 100 shareholdings.


  2. Batu Biologics Utilizes CRISPR/cas9 Gene Editing To Modify T CellsRead the original story

    16 hrs ago | BioSpace

    Batu Biologics , an immuno-oncology company, has recently filed intellectual property and initiated discovery research on a new method of augmenting an anti-tumor immune response through ex vivo manipulation of the patient's T cells. "Batu Biologics plans to utilize this groundbreaking technology to support our efforts in harnessing and unleashing the power of the patient's immune system.


  3. Stocks Drop On Weak Jobs Data; Caterpillar, Alexion Back OffRead the original story w/Photo

    24 min ago | Investor's Business Daily

    ... moving average and taking its loss for the week to 11%. ) dropped nearly 3% after reporting the Food and Drug Administration had extended for three months the deadline for an approval decision of the company's Kanuma as a treatment for a metabolic ...


  4. Atossa Genetics Inc. to Present at the Rodman & Renshaw 17th Annual Global Investment ConferenceRead the original story w/Photo

    46 min ago | Market Wire

    Steven C. Quay, M.D., Ph.D., CEO and President of Atossa will present the company's business model and growth strategy at 5:05 to 05:30 PM in Louis XVI B . In addition, a live audio webcast of Dr. Quay's presentation can be accessed via the following link: .


  5. HIV prevention program undergoes "real world" evaluationRead the original story w/Photo

    1 hr ago | Medical News

    ... were diagnosed. The study has been carried out after clinical trial results convinced the Food and Drug Administration and Centers for Disease Control and Prevention that PrEP should be recommended for the prevention of HIV among people who are HIV ...


  6. WHO sounds alarm over big Indian supplier of tuberculosis drugsRead the original story

    1 hr ago | Reuters

    ... stop buying from Svizera if the problems are not rectified within a reasonable time. The U.S. Food and Drug Administration has previously imposed sanctions on a number of Indian drugmakers, causing severe problems for companies such as Ranbaxy, now ...


  7. Truvada for HIV prevention proves highly effectiveRead the original story w/Photo

    1 hr ago | The Raw Story

    ... tenofovir) was originally developed as an antiviral drug for managing HIV, but in 2012 the U.S. Food and Drug Administration (FDA) approved it as a daily prophylactic pill for patient populations at highest risk for HIV, such as gay men with ...


  8. FDA delays decision on key Alexion drug by 3 monthsRead the original story

    1 hr ago | Reuters

    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. European health regulators on Tuesday approved the drug, Kanuma, to treat lysosomal acid lipase deficiency , a progressive metabolic disease that often leads to liver failure, multi-organ damage and premature death. The FDA, which has granted the drug "breakthrough therapy" status for LAL deficiency in infants, was expected to make its decision by Sept.


  9. IGI Laboratories, Inc. Announces Seventh ANDA Submission Of 2015Read the original story

    1 hr ago | Freshnews

    IGI Laboratories, Inc. , a New Jersey based specialty generic pharmaceutical company, today announced it has submitted its seventh abbreviated new drug application to the U.S. Food and Drug Administration of 2015, which brings the Company's total number of ANDA submissions now pending at the FDA to twenty-nine. Jason Grenfell-Gardner, President and CEO of the Company, commented, "We believe our current pipeline of twenty-nine submissions, exclusive of our four partnered submissions, pending approval by the FDA now has a combined addressable market of over $1.4 billion based on July 2015 data from IMS Health."


  10. Insider Selling: Eric A. Md Rose Sells 20,000 Shares of SIGA Technologies StockRead the original story

    2 hrs ago |

    ... BioShield. Arestvyr is an investigational product that is not currently approved by the U.S. Food and Drug Administration (FDA) as a treatment of smallpox or any other indication. Receive News & Ratings for SIGA Technologies Daily - Enter your email ...


  11. AstraZeneca to Update on Leading Lung Cancer Portfolio at WCLC 2015Read the original story

    2 hrs ago | Benzinga

    ... in 188 US cancer patients outside the clinical trial setting. IRESSAA was approved by the US Food and Drug Administration (FDA) in July 2015, and is already available in 91 countries worldwide. ATLANTIC (NCT02087423): A Phase II trial of durvalumab ...


  12. Fitchburg Fire Dept. takes its best shot in OD battleRead the original story w/Photo

    3 hrs ago | Sentinel & Enterprise

    ... Pilot Expansion. In addition to these kits, 4,000 auto-injectors, newly approved by the Food and Drug Administration, were donated to the state by Evzio manufacturer Kaleo. "All eligible first-responder communities were offered a share of the Kaleo ...


  13. Alexion Receives Notification of PDUFA Date Extension for Kanuma ...Read the original story w/Photo

    3 hrs ago | Investor's Business Daily

    Alexion Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act date for its Priority Review of the Company's Biologics License Application for Kanuma a , an investigational enzyme replacement therapy for the treatment of lysosomal acid lipase deficiency . The previously disclosed September 8, 2015 PDUFA date has been extended by the standard extension period of three months.


  14. Novartis wins EU approval for multiple myeloma drug FarydakRead the original story

    3 hrs ago | Reuters

    Novartis AG said on Friday it received European Union approval for Farydak, a treatment for multiple myeloma that the company said gives new options for adult patients whose disease has progressed following standard therapy. Novartis received similar approval for Farydak from the U.S. Food and Drug Administration in February for treating multiple myeloma, a form of blood cancer that arises from plasma cells found in bone marrow.


  15. Leadless pacemaker helps patient get back outdoorsRead the original story w/Photo

    4 hrs ago | News 4 Jax

    ... life has gotten really good," added Johnson. The leadless pacemaker is not yet approved by the Food and Drug Administration. It's currently designed for someone who only needs one chamber of the heart stimulated: that's about 10-percent of people ...


  16. Cosmo gets U.S. approval for agent aimed at easing polyp removalRead the original story

    4 hrs ago | Reuters

    Cosmo Pharmaceuticals SA said on Friday that the U.S. Food and Drug Administration has given marketing authorization for SIC 8000, a product used in gastrointestinal tract procedures.


  17. FDA Grants Breakthrough Therapy Designation for...Read the original story

    5 hrs ago | Benzinga

    Genentech, a member of the Roche Group , today announced that the U.S. Food and Drug Administration has granted breakthrough therapy designation to ACE910 for the prophylactic treatment of people who are 12 years or older with hemophilia A with factor VIII inhibitors. Hemophilia A, a rare genetic disorder, occurs when an essential blood clotting protein called factor VIII is either not present in sufficient amounts or is defective.


  18. Repeated exposure to anesthesia early in life causes long-term behavioral changesRead the original story w/Photo

    6 hrs ago | Medical News

    Repeated exposure to anesthesia early in life causes alterations in emotional behavior that may persist long-term, according to a study from the Icahn School of Medicine at Mount Sinai in collaboration with the Yerkes National Primate Research Center, and published in the Online First edition of Anesthesiology , the official medical journal of the American Society of Anesthesiologists. Each year, approximately one million children under the age of four undergo surgery with general anesthesia, according to the U.S. Food and Drug Administration .


  19. Read Full ArticleRead the original story w/Photo

    7 hrs ago | WKRC-AM Cincinnati

    Last week, the FDA issued its first cybersecurity warning about a specific medical device, urging healthcare facilities to stop using Hospira's Symbiq Infusion System Dr. John Halamka, CIO of Beth Israel Deaconess Medical Center wrote "My view is that this will be the first of many advisories" for cybersecurity vulnerabilities in medical devices Hacked medical devices are a double whammy, they might not only be hacked to impact patient care, they could also harbor and spread more traditional malware Some device makers have resisted beefing up security due to concerns that they'll need to re-certify devices with the FDA Healthcare organizations need to take extra precautions to isolate and secure smart devices and to ensure that they are patched when the manufactures release patches.


  20. Nordic Stocks - Factors to watch on Sept 4Read the original story

    7 hrs ago | Reuters

    The budget airline reported August traffic data that showed a growth of 9 percent in revenue passenger kilometres and a higher yield than August last year. The dual-listed drug maker said the U.S. Food and Drug Administration has approved an expanded indication for its brilinta drug.