The FDA approved Merck’s once-daily HIV regimen Idvynso (doravirine/islatravir) for adults with HIV-1 who are virologically suppressed, with no history of virologic treatment failure and no known resistance-associated substitutions to doravirine. The approval gives Merck a new in-market option as it competes in a space many biotechs have exited. The drug is supported by review progress aligned with a late April PDUFA timeline. Merck positioned Idvynso as a two-drug combination intended to simplify treatment for eligible patients while maintaining suppression in a defined population. For biotech and pharma, the approval matters because it reinforces a current push toward regimen simplification and longer-term positioning in HIV beyond injectable or multi-daily approaches. It also adds another benchmark for oral combination performance in real-world treatment patterns and payer coverage discussions.