Specialist HIV company ViiV Healthcare has submitted a supplemental new drug application (sNDA) to the US Food and Drug Administration (FDA) to expand the use of Cabenuva.

Specialist HIV company ViiV Healthcare has secured approval from the US Food and Drug Administration (FDA) for its Dovato (dolutegravir/lamivudine) as a complete regimen to treat HIV-1 infection.

ViiV Healthcare, the global specialist HIV company majority owned by GSK, with Pfizer and Shionogi Limited as shareholders, today announced that the company will be developing the investigational broadly neutralising antibody (bNAb) N6LS for the treatment and prevention of HIV-1, as part of an exclusive licensing agreement between GSK and the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).

HIV-focused ViiV Healthcare submitted a New Drug Application to the U.S. Food and Drug Administration (FDA) for potential approval of its investigational combination treatment for HIV-1. Submission of the NDA comes less than a month after ViiV snagged regulatory approval of Dovato.

Gilead Sciences has reported 96-week results from a phase 3, randomized, double-blinded study evaluating the safety and efficacy of Biktarvy (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg tablets) for the treatment of HIV-1 infection in treatment-naïve adults.