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FDA approves Epclusa for treatment of chronic Hepatitis C virus infection

FDA logo - cropped - May 2016

First regimen to treat all six major HCV genotypes The U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus (HCV) both with and without cirrhosis (advanced liver disease). For patients with moderate to severe cirrhosis (decompensated cirrhosis), Epclusa is approved for use in combination with the drug ribavirin….

FDA Launches Campaign that Affirms LGBT Young Adults’ Freedom to Be, Tobacco Free

FDAThisFreeLife - cropped May 2016

Last week, I had the privilege of participating in the launch of “This Free Life,” the Food and Drug Administration’s (FDA) new anti-smoking campaign for lesbian, gay, bisexual and transgender (LGBT) young adults. This is FDA’s first-ever national campaign designed to prevent and reduce tobacco use among LGBT young adults (ages 18-24) who are occasional…

Federal Work Group Looks to Future of Viral Hepatitis Action Plan

Federal Viral Hepatitis Leadership group - March 2016

Viral hepatitis is a growing public health problem in the United States. This increase is being fueled in part by the widespread epidemic of opioid abuse that is devastating families and communities across the country. These new cases add to the millions of people who are already living with viral hepatitis, many of whom have…

Califf, FDA top officials call for sweeping review of agency opioids policies

FDA

Editor’s Note: Reducing opioid misuse not only reduces deaths from overdose but is also key to reducing new HIV and viral hepatitis infections among persons who inject drugs. For more on the link between opioid misuse, HIV and viral hepatitis, see this CDC report. In response to the opioid abuse epidemic, today Dr. Robert Califf, the…

FDA approves Zepatier for treatment of chronic hepatitis C genotypes 1 and 4

FDA

The U.S. Food and Drug Administration today approved Zepatier (elbasvir and grazoprevir) with or without ribavirin for the treatment of chronic hepatitis C virus (HCV) genotypes 1 and 4 infections in adult patients. Hepatitis C is a viral disease that causes inflammation of the liver that can lead to diminished liver function or liver failure….

FDA updates blood donor deferral policy to reflect the most current scientific evidence and continue to ensure the safety of the U.S. blood supply

FDA

Today, the U.S. Food and Drug Administration issued final guidance outlining updated blood donor deferral recommendations to reflect the most current scientific evidence and to help ensure continued safety of the blood supply by reducing the risk of human immunodeficiency virus (HIV) transmission by blood and blood products. “The FDA’s responsibility is to maintain a…

FDA Issues Final Industry Guidance for Developing Antiretroviral Drugs for HIV Treatment

FDA

This week, FDA announced the availability of a final guidance [PDF 610 KB] for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral Drugs for Treatment.” The guidance provides recommendations for the development of antiretroviral drugs regulated within the FDA Center for Drug Evaluation and Research for the treatment of HIV infection. This guidance assists sponsors in…

FDA approves new treatment for HIV

FDA

The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir alafenamide) as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older. The CDC estimates that 1.2 million persons ages 13 years and older are living…