Posted by Michael Wonder on 23 Jun 2026
ViiV Healthcare advances paediatric HIV regulatory submissions with FDA priority review for Tivicay PD and EMA validation of marketing application for Tivicay
22 June 2026 - ViiV Healthcare today announced that the US FDA has accepted the supplemental new drug application to extend the use of Tivicay PD (dolutegravir) to newborns from birth.
The FDA has granted priority review for this application and assigned a PDUFA action date of 25 August 2026.
The EMA has also validated the marketing application for Tivicay, as the company continues to focus on addressing one of the most persistent gaps in care by expanding age-appropriate treatment options for the earliest stage of life.
