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May 01, 2026
FDA grants Priority Review for Gilead's bictegravir/lenacapavir single-tablet HIV regimen. The NDA is supported by ARTISTRY-1 and ARTISTRY-2 trials showing noninferiority. A PDUFA target date of August 27, 2026 has been set.
Feb 27, 2026
Merck announced Phase 3 trial results for its investigational once-daily, two-drug HIV regimen doravirine/islatravir at CROI 2026, demonstrating non-inferiority to standard treatment in treatment-naïve adults with viral suppression rates of 91.8% at Week 48.
Feb 26, 2026
A once-daily single-tablet combination of bictegravir and lenacapavir demonstrated non-inferiority to existing HIV treatments in Phase 3 trials, offering simplified treatment for people living with HIV who are virologically suppressed.
