Posted by Michael Wonder on 30 Apr 2026
US FDA grants priority review of new drug application for Gilead’s once daily HIV treatment of bictegravir plus lenacapavir
29 April 2026 - Gilead Sciences today announced the US FDA accepted its new drug application submission for bictegravir 75 mg/lenacapavir 50 mg – an investigational, once-daily single-tablet combination regimen for the treatment of HIV in adults who are virologically suppressed.
The FDA has granted priority review of the application and assigned a PDUFA action date of 27 August 2026.
