ViiV Healthcare advances paediatric HIV regulatory submissions with FDA Priority Review for Tivicay PD and EMA validation of marketing application for Tivicay
London – ViiV Healthcare, the global specialist HIV company majority owned by GSK, announced that the U.S. Food and Drug Administration (FDA) has accepted the supplemental New Drug Application (sNDA) to extend the use of Tivicay PD (dolutegravir (DTG)) to newborns from birth. The FDA has granted Priority Review for this application, with a Prescription…









