Foster City, Calif., July 30, 2025 – Gilead Sciences, Inc. (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted a new approval for a novel indication for Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets, B/F/TAF). This new indication expands Biktarvy’s label to include the treatment of people with HIV (PWH) with an antiretroviral treatment (ART) history who are not virologically suppressed, with no known or suspected resistance to the integrase strand inhibitor (INSTI) class, emtricitabine or tenofovir. The approval of this supplemental New Drug Application (sNDA) will help bridge an unmet public health need in PWH who are viremic and restarting ART given the limited treatment options approved by the FDA for this population to date.
Read the full company press release here.
Source : Gilead Sciences, Inc.
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