11-13-2015This week, FDA announced the availability of a final guidance for industry entitled “Human Immunodeficiency Virus-1 Infection: Developing Antiretroviral D…
11-10-2015The U.S. Food and Drug Administration today approved Genvoya (a fixed-dose combination tablet containing elvitegravir, cobicistat, emtricitabine, and tenofovir …
8-7-2015
On July 28, the U.S. Department of Health and Human Services (HHS) hosted the fifth annual observance of World Hepatitis Day to continue raising awareness o…
5-18-2015In a Federal Register notice published Friday, May 15, 2015, the Food and Drug Administration (FDA) is inviting public comments on the following draft recommend…
12-31-20142014 has been a year of both opportunities and challenges in the fight against viral hepatitis. In May, the World Health Assembly passed a new resolution on vir…
12-23-2014The U.S. Food and Drug Administration is a science-based regulatory agency that works to protect and promote the public health. In this role, it is our responsi…
12-19-2014The U.S. Food and Drug Administration today approved Viekira Pak (ombitasvir, paritaprevir and ritonavir tablets co-packaged with dasabuvir tablets) to treat pa…
10-14-2014The U.S. Food and Drug Administration today approved Harvoni (ledipasvir and sofosbuvir) to treat chronic hepatitis C virus (HCV) genotype 1 infection.Harvoni i…
7-30-2014Transformative advances in drug treatments approved by the Food and Drug Administration are giving the 3.2 million Americans with chronic hepatitis C a chance f…
12-9-2013Drug is third with breakthrough therapy designation to receive FDA approvalThe U.S. Food and Drug Administration today approved Sovaldi (sofosbuvir) to treat ch…
