Articles By Cyndi Root

  1. Pfizer Announces Positive Study Results For Prevenar 13 For Pneumonia 3/5/2014

    Pfizer Inc. announced in a press release that Prevnar 13 has achieved successful results in a large clinical study.

  2. Amarin Announces FDA Award Of Three-Year Exclusivity For Vascepa, Sues For Five Years 3/5/2014

    Amarin Corporation announced in a press release that the Food and Drug Administration (FDA) awarded marketing exclusivity to Vascepa (icosapent ethyl) capsules.

  3. Weekly FDA Enforcement Report For Drugs And Biologics 2/25/2014

    The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for February 19, 2014.

  4. Spinifex Pharmaceutical's Trial Of EMA401 Shows Efficacy in Postherpetic Neuralgia 2/25/2014

    Spinifex Pharmaceuticals announced via a press release results from a clinical trial of EMA401 published in The Lancet.

  5. FDA Gives Some Drugmakers Expedited Import Entry Review 2/25/2014

    The Food and Drug Administration (FDA) has launched the Secure Supply Chain Pilot Program. The pilot program, running from February 2014 through February 2016, allows approved companies to receive expedited import review.

  6. FDA To Review Merck's V503 HPV Vaccine 2/25/2014

    Merck announced in a press release that the Food and Drug Administration (FDA) has decided to review its V503 vaccine.

  7. The FDA And European Medicines Agency Agree To Pharmacovigilance Cooperation 2/25/2014

    The Food and Drug Administration (FDA) announced via press release that the federal agency and the European Medicines Agency (EMA) have agreed to cooperate on pharmacovigilance.

  8. FDA Accepts Regado Biosciences' Application For REG2 2/25/2014

    Regado Biosciences, Inc. announced in a press release that the Food and Drug Administration (FDA) has approved its investigational new drug (IND) application for REG2 for venous thrombosis.

  9. FDA Gives Topotarget Acceptance To File For Beleodaq 2/21/2014

    Topotarget announced in a press release that the Food and Drug Administration (FDA) has given acceptance to file for Beleodaq.

  10. Weekly FDA Enforcement Report For Drugs And Biologics 2/19/2014

    The Food and Drug Administration (FDA) has released its Drug and Biological product Enforcement Report for February 12, 2014. The agency publicizes recalls in its weekly report, as press releases are not issued for all recalls. Manufacturers issue recalls voluntarily or the FDA initiates the action. Recalls can be viewed by Biologics or Drugs, and by Classification, the danger level. 

    Classification I Recall