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…
10-21-2013On September 25, 2013, the Food and Drug Administration (FDA) issued a Drug Safety Communication announcing that the FDA has approved changes to the prescribing…
8-8-2013The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen…
6-28-2013The U.S. Food and Drug Administration today approved a test that identifies the genotype of hepatitis C virus (HCV) that a patient is carrying. The Abbott RealT…
