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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 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…

FDA approves Viekira Pak to treat hepatitis C

FDA

The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat patients with chronic hepatitis C virus (HCV) genotype 1 infection, including those with a type of advanced liver disease called cirrhosis. Hepatitis C is a viral disease that causes inflammation of the liver that…

FDA approves first combination pill to treat hepatitis C

FDA

The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection. Harvoni is the first combination pill approved to treat chronic HCV genotype 1 infection. It is also the first approved regimen that does not require administration with interferon or ribavirin, two FDA-approved drugs…

Faster, Easier Cures for Hepatitis C

ucm405643

Transformative advances in drug treatments approved by the Food and Drug Administration are giving the 3.2 million Americans with chronic hepatitis C a chance for a longer, healthier life without the virus. That’s welcome news for baby boomers—who make up three of four adults with the hepatitis C virus—and millions of other Americans, many of…

FDA approves Sovaldi for chronic hepatitis C

FDA

Drug is third with breakthrough therapy designation to receive FDA approval The U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat chronic hepatitis C virus (HCV) infection. Sovaldi is the first drug that has demonstrated safety and efficacy to treat certain types of HCV infection without the need for co-administration of interferon. “Today’s…