GILD CHMP opinion: Thursday, July 23, 2026
Variation type II · Biktarvy · Submission of the final report from study GS‑US‑380‑1474 listed as a category 3 study in the RMP. This is a Phase 2/3, Open-Label Study of the Pharmacokinetics, Safety, and Antiviral Activity of the GS-9883/Emtricitabine/Tenofovir Alafenamide (GS-9883/F/TAF) Fixed Dose
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