Gilead Sciences has refiled for FDA approval of its HIV capsid inhibitor lenacapavir – which only needs to be dosed every six months – after the drug was rejected by the regulator in February.

KISII, Kenya, Oct 23 – The U.S Food and Drug Administration ( FDA) has confirmed the availability of lenacapavir, a two yearly injectable HIV/ADS treatment as early as summer 2025, a decision made by ...

The treatment combines MSD’s islatravir with Gilead’s lenacapavir. Credit: Ground Picture via Shutterstock. Gilead Sciences and MSD are advancing their once-weekly HIV treatment regimen to Phase II ...

A mole is also known as a melanocytic nevus or simply a nevus. They are usually round, brown/pink macules, papules, or nodules. They can be found anywhere on the body and may appear at any age. Moles ...

lenacapavir reduced HIV infections by 96% ... The most common side effect was the formation of harmless subcutaneous nodules, which typically decreased with subsequent injections.

Along with these most recent study results, the potent antiviral activities, and pharmacokinetic profiles of islatravir and lenacapavir support their continued development as an investigational ...

But in terms of HIV preventions, there is already another groundbreaking drug called lenacapavir. The anti-HIV compound is already in use, but getting the drug to those who need it most could ...

In June 2024, Gilead released data from the Phase III PURPOSE 1 study, announcing that its investigational PrEP shot lenacapavir showed 100% efficacy in preventing HIV in cisgender women. Gilead ...

But will doctors use it? In its push to gain approval for its long-acting answer lenacapavir, Gilead also has reported stellar results from two phase 3 trials including the PURPOSE 1 study ...

1. In this randomized controlled trial, among adolescent girls and young women, it was found that twice-yearly lenacapavir resulted in a significantly reduced human immunodeficiency virus (HIV) ...