SILVER SPRING, Md., Feb. 1, 2012 /PRNewswire-USNewswire/ -- The FDA and representatives from the medical device industry have reached an agreement in principle on proposed recommendations for the third reauthorization of a medical device user fee program. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The recommendations would authorize the FDA to collect $595 million ... read more

Confirmatory trials show significantly prolonged survival in patients; drug granted regular approval SILVER SPRING, Md., Jan. 31, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today granted Gleevec (imatinib) regular approval for use in adult patients following surgical removal of CD117-positive gastrointestinal stromal tumors (GIST). Today's action ... read more

Breakthrough therapy targets defective protein SILVER SPRING, Md., Jan. 31, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Kalydeco (ivacaftor) for the treatment of a rare form of cystic fibrosis (CF) in patients ages 6 years and older who have the specific G551D mutation ... read more

SILVER SPRING, Md., Jan. 30, 2012 /PRNewswire-USNewswire/ -- Today, Erivedge (vismodegib) was approved by the U.S. Food and Drug Administration to treat adult patients with basal cell carcinoma, the most common type of skin cancer. The drug is intended for use in patients with locally advanced basal ... read more

Drug helps keep cancer from progressing SILVER SPRING, Md., Jan. 27, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today approved Inlyta (axitinib) to treat patients with advanced kidney cancer (renal cell carcinoma) who have not responded to another drug for this type of cancer. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ) ... read more

Generic drug manufacturer agrees to remedy deviations from the current good manufacturing practice requirements and to correct data integrity problems at numerous facilities SILVER SPRING, Md., Jan. 25, 2012 /PRNewswire-USNewswire/ -- The Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a consent ... read more

Inspection found Listeria monocytogenes in manufacturing facility, equipment SILVER SPRING, Md., Jan. 24, 2012 /PRNewswire-USNewswire/ -- A Maine food processing and storage company destroyed its cold smoked salmon product under the supervision of the U.S. Food and Drug Administration after inspectors found Listeria monocytogenes within the firm's facility and on ... read more

SILVER SPRING, Md., Jan. 20, 2012 /PRNewswire-USNewswire/ -- Today, the U.S. Food and Drug Administration allowed marketing of the first test to help determine the risk for a rare brain infection called progressive multifocal leukoencephalopathy (PML) in people using the drug Tysabri (natalizumab) to treat multiple sclerosis (MS) or Crohn's ... read more

Helps lower high blood levels of the chemotherapy drug SILVER SPRING, Md., Jan. 17, 2012 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today approved Voraxaze (glucarpidase) to treat patients with toxic levels of methotrexate in their blood due to kidney failure. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Methotrexate is a commonly used cancer chemotherapy drug normally eliminated ... read more

SILVER SPRING, Md., Jan. 17, 2012 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of January 16, 2012. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) FDA News & Notes does not contain ... read more

SILVER SPRING, Md., Jan. 13, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today expanded the approved usage for an endovascular graft manufactured by W.L. Gore and Associates Inc. to include treatment of life-threatening tears or ruptures of the aorta (thoracic aortic transection). (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) The Gore TAG Thoracic Endoprosthesis is ... read more

SILVER SPRING, Md., Jan. 13, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration has completed its recommendations for three user fee programs that will help speed safe and effective drugs and lower-cost generic drug and biosimilar biological products to patients, FDA Commissioner Margaret A. Hamburg, M.D. said today. The ... read more

SILVER SPRING, Md., Jan. 9, 2012 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of January 9, 2012. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) FDA News & Notes does not contain ... read more

SILVER SPRING, Md., Jan. 6, 2012 /PRNewswire-USNewswire/ -- Stem cells therapies offer the potential to treat diseases or conditions that are currently incurable or for which few treatments exist. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) But the Food and Drug Administration (FDA) is concerned that the hope that patients have for elusive cures may leave ... read more

Agency issues order prohibiting certain uses in food-producing animals SILVER SPRING, Md., Jan. 4, 2012 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today issued an order that prohibits certain uses of the cephalosporin class of antimicrobial drugs in cattle, swine, chickens and turkeys effective April 5, 2012. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Antimicrobial drugs are ... read more

SILVER SPRING, Md., Jan. 3, 2012 /PRNewswire-USNewswire/ -- Science, public health, and regulatory highlights from the U.S. Food and Drug Administration. Information in this document is designed for credentialed journalists. Release dates and times for items are current as of January 2, 2012. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) FDA News & Notes does not contain ... read more

SILVER SPRING, Md., Dec. 30, 2011 /PRNewswire-USNewswire/ -- Prevnar 13, a pneumococcal 13-valent conjugate vaccine, was approved today by the U.S. Food and Drug Administration for people ages 50 years and older to prevent pneumonia and invasive disease caused by the bacterium, Streptococcus pneumoniae. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ) Pneumococcal pneumonia, caused when ... read more

SILVER SPRING, Md., Dec. 29, 2011 /PRNewswire-USNewswire/ --The U.S. Food and Drug Administration today approved a single shared Risk Evaluation and Mitigation Strategy (REMS) for the transmucosal immediate-release fentanyl (TIRF) products. This new shared system will replace the individual REMS and allow prescribers and pharmacies to enroll into just one ... read more

SILVER SPRING, Md., Dec. 28, 2011 /PRNewswire-USNewswire/ -- Some medical devices are reused many times in surgical and exploratory procedures. They include instruments used in surgery (like clamps and forceps), and endoscopes (like bronchoscopes and colonoscopes) used to visualize areas inside the body. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO ) FDA has received reports of patient ... read more

SILVER SPRING, Md., Dec. 27, 2011 /PRNewswire-USNewswire/ -- Consumers are warned not to use the ShoulderFlex Massager--a home massager that has caused a death and a near-strangulation when a necklace and clothing became caught in the device. (Logo: http://photos.prnewswire.com/prnh/20090824/FDALOGO) Other alerts or safety information issued by the Food and Drug Administration in ... read more