FDA approves generic lenacapavir for low-income markets; EMA to review Lundbeck's Deanxit over safety concerns

The U.S. Food and Drug Administration has granted approval for a generic version of lenacapavir, a drug aimed at treating HIV, with the intention of making it available to lower-income countries.

Lenacapavir, originally approved as a branded capsid inhibitor, is expected to become more affordable through this generic launch, potentially expanding patient access.

In Europe, the European Medicines Agency has initiated a review of Lundbeck's psychiatric medication Deanxit after reports of serious safety concerns have emerged.

These regulatory moves underscore the dual focus on improving drug accessibility while maintaining vigilance over product safety.