FDA tentatively approves Dr Reddy's generic twice-yearly HIV prevention shot

Dr Reddy's is the first of six Gilead-licensed manufacturers to receive tentative FDA approval for generic lenacapavir, a twice-yearly HIV prevention shot. The designation means the drug meets FDA safety, efficacy and quality standards but cannot yet be sold in the US because of patent or exclusivity issues. Global health agencies expect it to cost $40 a year, and Dr Reddy's expects a broader rollout in eligible countries in 2027.