Feed: FDA News - AggScore: 46.1

FDA Approvals - Celldex Therapeutics and Neptune Strong Performers in a Booming IndustryNEW

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Celldex Therapeutics and Neptune Strong Performers in a Booming IndustryNEW YORK, NY-- - The Biotechnology Industry has shown investors some impressive gains this year. The SPDR S&P Biotech ETF is up nearly 25 percent year-to-date. As large pharmaceuticals face major patent ......

FDA Approvals - Genetic Technologies and Complete Genomics Strong Performers in a Booming

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Genetic Technologies and Complete Genomics Strong Performers in a Booming IndustryNEW YORK, NY-- - The Biotechnology Industry has shown investors some impressive gains this year. The SPDR S&P Biotech ETF is up nearly 25 percent year-to-date. As large pharmaceuticals face major patent ...Biotech Industry Booming in 2012NEW YORK, NY-- - The Biotechnology Industry has shown investors some impressive gains this year. The SPDR S&P Biotech ETF is up nearly 25 percent year-to-date. A flurry of mergers & acquisitions activity...

FDA expands use for FilmArray Respiratory Panel The U.S. Food

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FDA expands use for FilmArray Respiratory Panel The U.S. Food and Drug Administration today expanded the use for the FilmArray Respiratory Panel, the first test that can simultaneously detect both viral and bacterial causes of respiratory infection from a single sample....

FDA strengthens international collaboration to ensure quality, safety of imported

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FDA strengthens international collaboration to ensure quality, safety of imported products The U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency s Global Engagement Report [INSERT HYPERLINK], detailing the many activities and strategies FDA is using to transform from a domestic to a global public health agency....

FDA s $6.4 Billion Drug, Device Review Fee Plan Passes SenateThe

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FDA s dollarsignr6.4 Billion Drug, Device Review Fee Plan Passes SenateThe U.S. Senate voted to let regulators collect on a dollarsignr6.4 billion fee agreement struck with Eli Lilly & Co. (LLY) , Medtronic Inc. (MDT) and other companies to fund reviews of new drugs and medical devices through 2017.FDA's dollarsignr6.4B drug, device review fee plan passes US SenateThe U.S. Senate voted to let regulators collect on a dollarsignr6.4 billion fee agreement struck with Eli Lilly & Co., Medtronic Inc....

FDA Approvals - M&A Activity and a Growing Rate of FDA Approvals Contributing

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M&A Activity and a Growing Rate of FDA Approvals Contributing Factors to Biotech Industry's Success The Paragon Report ...NEW YORK, NY-- - The Biotechnology Industry has shown investors some impressive gains this year. The SPDR S&P Biotech ETF is up nearly 25 percent year-to-date. A flurry of mergers & acquisitions activity ...Genetic Technologies and Complete Genomics Strong Performers in a Booming IndustryNEW YORK, NY-- - The Biotechnology Industry has shown investors some impressive gains this year. The SPDR S&P...

FDA approves Votrient for advanced soft tissue sarcoma The U.S.

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FDA approves Votrient for advanced soft tissue sarcoma The U.S. Food and Drug Administration today approved Votrient (pazopanib) to treat patients with advanced soft tissue sarcoma who have previously received chemotherapy. Soft tissue sarcoma is a cancer that begins in the muscle, fat, fibrous tissue, and other tissues....

CDC report: More teen girls use best birth controlMore teen

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CDC report: More teen girls use best birth controlMore teen girls now use the best kinds of birth control, a new government study says.Health officials debate cost of teen pregnancies Family planning is our top priority, reported Dr. Claude Burnett, director of the Northeast Georgia Health District at a meeting of the Jackson County Board of Health on April 25.Implants may help prevent repeat teen pregnanciesNEW YORK (Reuters Health) - Up to half of teens and young women who...

Therapy Cool Path Duo Ablation Catheter, Safire BLU Duo Ablation

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Therapy Cool Path Duo Ablation Catheter, Safire BLU Duo Ablation Catheter, and IBI1500T9-CP V1.6 Cardiac Ablation Generator The Therapy Cool Path Duo Ablation Catheter or the Safire BLU Duo Ablation Catheter is a steerable, deflectable, irrigated catheter (a long, thin, flexible tube) used to treat a certain kind of abnormal heart rhythm (arrhythmia2) called typical atrial.. (Approved: 1/25/2012)...

Honeyville Honey Farm Issues Allergy Alert on Undeclared Anchovy in

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Honeyville Honey Farm Issues Allergy Alert on Undeclared Anchovy in Honeyville Honey Barbecue Sauce Honeyville Honey Farm of Durango, CO is voluntarily recalling bottles of Honeyville Honey Barbecue Suace manufactured after August 1, 2011 because they contain undeclared anchovies in the Worcestershire sauce used in production. People who have allergies to anchovies run the risk of serious or life threatening allergic reaction if they consume these products. Gills Onions Voluntarily Recalls One Lot of Diced Red Onions Because of...

FDA Approvals - M&A Activity and Growing Rate of FDA Approvals Contributing Factors

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M&A Activity and Growing Rate of FDA Approvals Contributing Factors to Biotech Industry's Recent BoomNEW YORK, NY-- - The Biotechnology Industry has shown investors some impressive gains this year. The SPDR S&P Biotech ETF is up nearly 25 percent year-to-date. A flurry of mergers & acquisitions activity ......

FDA Approvals - Should Congress Allow FDA To Give Reversible Drug Approvals?Avik Roy

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Should Congress Allow FDA To Give Reversible Drug Approvals?Avik Roy and Matthew Herper discuss a proposal to give the FDA a new type of drug approval.FDA Approval for BSX Epic StentThe FDA approval of the Epic stent will strengthen the company???s Peripheral Interventions portfolioViral Genetics P-IND Clears FDA To Commence Clinical Trials in HumansA physician-initiated Investigational New Drug application submitted to the FDA in late April, 2012, has cleared the FDA s screening process with the requirement for a...

FDA-led research team discovers an autoimmune mechanism for serious drug-induced

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FDA-led research team discovers an autoimmune mechanism for serious drug-induced adverse reactions A team of researchers led by the U.S. Food and Drug Administration has discovered a new mechanism for identifying and understanding drug-related autoimmune reactions....

Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna

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Moon Marine USA Corporation voluntarily recalls frozen raw yellowfin tuna product Moon Marine USA Corporation (also known as MMI) of Cupertino, Calif. is voluntarily recalling 58,828 lbs of a frozen raw yellowfin tuna product, labeled as Nakaochi Scrape AA or AAA. Nakaochi Scrape is tuna backmeat, which is specifically scraped off from the bones, and looks like a ground product. The product is not available for sale to individual consumers, but may have been used to make sushi, sashimi,...

FDA s $6.4B drug review fee plan passes SenateThe U.S. Senate

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FDA s dollarsignr6.4B drug review fee plan passes SenateThe U.S. Senate voted to let regulators collect on a dollarsignr6.4 billion fee agreement struck with Indianapolis-based Eli Lilly and Co., Medtronic Inc. and other companies to fund reviews of new drugs and medical devices through 2017.FDA warns of sexual enhancement products and sends yet more letters for GMP violationsWe're watching you... FDA issued public notifications on May 16 th against three sexual enhancement products: " VMaxx Rx "; Firminite ;...