Gilead Sciences has a Prescription Drug User Fee Act (PDUFA) date of June 19 for lenacapavir, its twice-yearly long-acting injectable antiretroviral for pre-exposure prophylaxis (PrEP). This means that on the 19th (or earlier), the Food and Drug Administration (FDA) will decide whether to approve lenacapavir for PrEP, which many believe they will. Following approval, Gilead […]
