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01-04-2023Cross-posted from FDA News Release [On December 22, 2022], the U.S. Food and Drug Administration approved Sunlenca (lenacapavir), a new type of antiretroviral…
FDA
FDA Approves New HIV Drug for Adults with Limited Treatment Options - Blog
Participants Needed in Blood Donor Study: Could Lead to Eligibility Changes for Men Who Have Sex with Men 01-26-2022A pilot study funded by the U.S. Food and Drug Administration (FDA) that could potentially lead to changes to blood donor eligibility for men who have sex with… - Blog
FDA Approves First Extended-Release, Injectable Drug Regimen for Adults Living with HIV 01-22-2021Cross-posted from FDA Newsroom[Yesterday] the U.S. Food and Drug Administration approved Cabenuva (cabotegravir and rilpivirine, injectable formulation) as a… - Blog
Federal Agencies Highlight Ongoing Efforts to End HIV for World AIDS Day 12-07-2020During the December 1st observance of World AIDS Day 2020, our colleagues across the federal government highlighted their ongoing work to support the goals of… - Blog
FDA Approves New HIV Treatment for Patients With Limited Treatment Options 07-14-2020Cross-posted from U.S. Food and Drug Administration[On July 2, 2020], the U.S. Food and Drug Administration approved Rukobia (fostemsavir), a new type of… - Blog
FDA Approves Drug to Treat Infants and Children with HIV 06-16-2020On June 12, 2020, the U.S. Food and Drug Administration (FDA) approved Tivicay (dolutegravir) tablets and Tivicay PD (dolutegravir) tablets for suspension to… - Blog
New FDA Information on OraQuick In-Home HIV Test 06-11-2020The U.S. Food and Drug Administration (FDA) has published new information on the OraQuick In-Home HIV Test. This is the only FDA-approved in-home HIV test.As… - Blog
President Trump Announces Remdesivir Authorized for Emergency COVID-19 Treatment, Discusses Ending HIV and Hepatitis C 05-05-2020On May 1, 2020, President Donald J. Trump announced that the investigational antiviral drug remdesivir has been authorized by the U.S. Food and Drug… - Blog
Coronavirus (COVID-19) Update: FDA Provides Updated Guidance to Address the Urgent Need for Blood During the Pandemic 04-02-2020Cross-posted from U.S. Food and Drug AdministrationStatement from: Director - Center for Biologics Evaluation and Research (CBER), Peter Marks M.D., PhD.As… - Blog
FDA Launches Mobile-Friendly Database with Information on Life-Saving HIV Drugs 02-06-2020Cross-posted from U.S. Food and Drug Administration, Statement from Commissioner of Food and Drugs - Food and Drug Administration Stephen M. Hahn M.D.On Friday… - Blog
FDA’s Response to HIV: A Perspective from the Commissioner 10-03-2019In a recent two-part FDA Voices series, Acting FDA Commissioner Ned Sharpless, MD, discusses how the agency’s medical product centers are engaged in important… - Blog
FDA Approves First Two-drug Complete Regimen for HIV-infected Patients Who Have Never Received Antiretroviral Treatment 04-09-2019Cross-posted from FDA NewsroomOn April 8, 2019, the U.S. Food and Drug Administration approved Dovato (dolutegravir and lamivudine), as a complete regimen for… - Blog
Secretary Azar Addresses CDC’s National HIV Prevention Conference 03-20-2019The second plenary session at the CDC’s 2019 National HIV Prevention Conference featured remarks by HHS Secretary Alex Azar, thoughts on how we can get to no… - Blog
Recent HIV News from FDA 05-30-2018The Food and Drug Administration (FDA) has recently shared several HIV-related updates. In case you missed them, we are re-capping them below:On May 14, 2018,… - Blog
FDA Approves First Two-Drug Regimen for Certain Patients with HIV 11-27-2017Cross-posted from FDA NewsroomDirector’s Note from Richard Wolitski, Ph.D., Director, HHS Office of HIV/AIDS and Infectious Disease Policy: This news from FDA… - Blog
FDA HIV Update: Approval of Generic Emtricitabine and Tenofovir Disoproxil Fumarate Tablets, 200 mg/300 mg 06-29-2017Cross-posted from FDA Office of Health and Constituent Affairs Editor's Note: Generic drug approval by the FDA allows the generic drug to be marketed in the… - Blog
FDA Requests Removal of Opana ER for Risks Related to Abuse 06-29-2017Crossposted from FDA NewsroomNote: Earlier this month, the FDA requested that a drug company remove an opioid pain medication, Opana ER, from the market… - Blog
FDA Requests Removal of Opana ER for Risks Related to Abuse 06-29-2017Crossposted from FDA Newsroom Note: Earlier this month, the FDA requested that a drug company remove an opioid pain medication, Opana ER, from the market… - Blog
Health Information on the Web 03-07-2017Editor’s Note: It is important to have up-to-date information on health - learn what our colleagues at FDA have to say about finding up-to-date health… - Blog
FDA approves Epclusa for treatment of chronic Hepatitis C virus infection 06-30-2016First regimen to treat all six major HCV genotypesThe U.S. Food and Drug Administration approved Epclusa to treat adult patients with chronic hepatitis C virus…