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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…

FDA Safety Communication: Reducing the Risk of Hepatitis B Reactivation in Patients Using Two Immune-Suppressing and Anti-Cancer Drugs

FDA

On September 25, 2013, the Food and Drug Administration (FDA) issued a Drug Safety Communication announcing that the FDA has approved changes to the prescribing information of the immune-suppressing and anti-cancer drugs Arzerra (ofatumumab) and Rituxan (rituximab) to add new Boxed Warning information about the risk of reactivation of hepatitis B virus (HBV) infection. The…

FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies

FDA

The 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 as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens. Approved for use as an aid in the diagnosis of HIV-1…

FDA approves first genotyping test for patients with hepatitis C virus

FDA

The 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 RealTime HCV Genotype II, which can differentiate genotypes 1, 1a, 1b, 2, 3, 4, and 5,using a sample of an infected patient’s blood plasma or serum, will aid health…

FDA to Convene Meeting on HIV Patient-Focused Drug Development and HIV Cure Research

FDAMeeting

The Food and Drug Administration (FDA) wants to talk to people living with HIV (PLWH) and HIV/AIDS advocates. On June 14, under its Patient-Focused Drug Development initiative, FDA will ask PLWH to join an open public discussion about: the impact of HIV on your daily life, experience with currently available therapies to treat HIV, your…

World AIDS Day

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Cross-posted from the FDA Blog World AIDS Day has been observed in the United States on December 1 since 1995. When I look back at early World AIDS Day observances, I remember them as a way of raising awareness of the men, women and children who had no advocates, no representation, no medicines, and practically…

FDA approves first drug for reducing the risk of sexually acquired HIV infection

blog.aids.gov

Today (July 16, 2012), the U.S. Food and Drug Administration approved Truvada (emtricitabine/tenofovir disoproxil fumarate), the first drug approved to reduce the risk of HIV infection in uninfected individuals who are at high risk of HIV infection and who may engage in sexual activity with HIV-infected partners. Truvada, taken daily, is to be used for…

FDA Advisory Committees to Examine a Number of HIV Issues in May

FDA

The U.S. Food and Drug Administration (FDA) has three important advisory committee meetings scheduled in May that may impact HIV prevention, detection, and treatment. On May 10, 2012, FDA’s Antiviral Advisory Committee will discuss expanding the indication of Truvada (emtricitabine/tenofovir disoproxil fumarate) tablet, made by Gilead Sciences, Inc., to include use for Pre-Exposure Prophylaxis (PrEP),…

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