FDA Approves First Generic Long-Acting Injectable for HIV Prevention

The U.S. Food and Drug Administration (FDA) has approved the first generic long-acting injectable, lenacapavir, for HIV prevention. This approval, coming just 16 months after the originator product, is expected to make an affordable version of the twice-yearly injection available in 120 low- and middle-income countries by the end of 2026, significantly accelerating access to this highly effective prevention method.