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FDA Grants Priority Review for Bictegravir/Lenacapavir HIV Single-Tablet Regimen

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.

Merck's Two-Drug HIV Regimen Meets Primary Endpoint in Phase 3 Trial

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.