News Releases
Prevnar 13 Approved for New Age Category
Pfizer Inc. announced that the U.S. Food and Drug Administration (FDA) has granted approval of the Company’s pneumococcal conjugate vaccine Prevnar 13 ( Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]) as a single dose for use in adults. Prevnar 13 is indicated for adults 50 years of age and older for active immunization for the prevention of pneumonia and invasive disease caused by the 13 Streptococcus pneumoniae (S. pneumoniae ) serotypes contained in the vaccine.
First Therapy Approved in the EU for Neurodegenerative Disease
Pfizer announced that the European Commission has approved Vyndaqel (tafamidis) for the treatment of Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP) in adult patients with stage 1 symptomatic polyneuropathy. TTR-FAP is a rare, progressive and fatal neurodegenerative disease that affects approximately 8,000 patients worldwide.
FDA Approves New HIV Treatment
The U.S. Food and Drug Administration today approved Edurant (rilpivirine) in combination with other antiretroviral drugs for the treatment of HIV-1 infection in adults who have never taken HIV therapy (treatment-naïve).
National HIV Vaccine Awareness Day
Thirty years since the first report of the disease we now know as AIDS, scientists supported by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, continue advancing toward our goal of a vaccine to prevent HIV infection. I am optimistic that we will succeed.
FDA approves Victrelis for Hepatitis C
The U.S. Food and Drug Administration today approved Victrelis (boceprevir) to treat certain adults with chronic hepatitis C. Victrelis is used for patients who still have some liver function, and who either have not been previously treated with drug therapy for their hepatitis C or who have failed such treatment. Victrelis is approved for use in combination with peginterferon alfa and ribavirin.
FDA issues first new rules under Food Safety Modernization Act
The U.S. Food and Drug Administration today announced two new regulations that will help ensure the safety and security of foods in the United States. The rules are the first to be issued by the FDA under the new authorities granted the agency by the FDA Food Safety Modernization Act (FSMA), signed into law by President Obama in January. Both rules will take effect July 3, 2011.
A Plan to Help the Pre-existing Condition Crowd
The U.S. Department of Health and Human Services (HHS) is increasing awareness about a health plan for uninsured Americans with pre-existing conditions created by the Affordable Care Act.