FDA gives Dr. Reddy's tentative nod for generic lenacapavir

Dr. Reddy’s Laboratories received tentative FDA approval for the first generic injectable lenacapavir, a twice-yearly HIV prevention injection, just 16 months after Gilead’s originator product was approved. This rapid approval follows a pricing agreement and partnership with Unitaid, Wits RHI, and CHAI to accelerate affordable access to the treatment in 120 low- and middle-income countries by the end of 2026.

This Wire brief sits within Fusion42's coverage of Biotech, and 5 sources have reported it between 2 Nov 2026 and 3 Nov 2026.