-
FDA Approves Gilead's 'Game Changing' Twice-Yearly Shot To Prevent HIV Transmission, Critics Slam $28K Price Tag
20 Jun 2025 12:01 GMT
… U.S. Food and Drug Administration (FDA) approved Gilead Sciences, Inc … PURPOSE 2 trials remained HIV negative.
The first PrEP medication, which … once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil … .
In the PURPOSE 2 trial, there were two HIV …
-
Gilead Sciences' Yeztugo receives nod; the first and only US FDA─approved HIV prevention option offering 6 months of protection
20 Jun 2025 04:44 GMT
… once-daily oral Truvada (emtricitabine 200mg and tenofovir disoproxil fumarate … . In the PURPOSE 2 trial (NCT04925752), there were two … trials were published in The New England Journal of Medicine … countries for the treatment of multi-drug-resistant HIV in …
-
Lenacapavir Approved for Twice-Yearly Injection for HIV Prevention, a Landmark FDA Decision
20 Jun 2025 01:44 GMT
… and PURPOSE 2 (NCT04925752) trials, in which the therapy … MD, distinguished professor of medicine in the division of … and once-daily oral emtricitabine and tenofovir disoproxil fumarate … reduction associated with lenacapavir treatment when compared to …
-
Gilead's twice-yearly PrEP drug is cleared by FDA
18 Jun 2025 23:24 GMT
… 2, and in both trials the drug was significantly better at … daily oral PrEP product Truvada (emtricitabine and tenofovir disoproxil fumarate).
… there is a pool of treatment-naïve people who have … possible brakes on uptake like Medicaid cuts, saying: "We …
-
FDA Approves First Twice-Yearly Injectable PrEP for HIV Prevention
19 Jun 2025 22:04 GMT
… clinical trials
The FDA approval of Gilead’s New Drug Applications … once-daily oral Truvada® (emtricitabine 200mg and tenofovir disoproxil … of Medicine and, based in part on the trial results, … ’s HIV prevention and treatment research program. Lenacapavir is …
-
New HIV Prevention Drug Approved—Now Let’s Remove the Final Barrier
19 Jun 2025 21:47 GMT
… FDA already permits patients with treatment-resistant HIV to access the drug … (emtricitabine/tenofovir) sells for a dollar per pill.
… costs of visiting a doctor to obtain a prescription … options for purchasing OTC medications, including online services, …
-
Gilead Sciences’ twice-yearly HIV PrEP drug Yeztugo granted FDA approval
19 Jun 2025 11:55 GMT
… the late-stage PURPOSE 1 trial, which randomised over 5 … s once-daily oral PrEP drugs, Descovy (emtricitabine/tenofovir alafenamide) … Yeztugo group.
In both trials, Yeztugo also demonstrated superiority … epidemic.
“This is a medicine that only needs to be …
-
Injectable HIV Prevention Drug Gets FDA Nod
19 Jun 2025 08:34 GMT
… US Food and Drug Administration’s (FDA’s) approval of … oral combination therapy of emtricitabine and tenofovir disoproxil fumarate … Advancing Access medication assistance program will provide the drug at no … Therapy Designation by the FDA in October 2024 and …
-
FDA Approves Twice-Yearly Lenacapavir for HIV Prevention
19 Jun 2025 03:49 GMT
… the Food and Drug Administration (FDA) approved twice-yearly … combination regimen for treatment-experienced people with … fumarate/emtricitabine). Gilead’s Descovy pill (tenofovir disoproxil … will work with pharmaceutical manufacturers to offer …
-
FDA Approves Lenacapavir for Prevention of HIV
19 Jun 2025 01:42 GMT
… and PURPOSE 2 (NCT04925752) trials, in which the therapy met … MD, distinguished professor of medicine in the Division of … multicenter, randomized phase 3 trial evaluating the safety and … and once-daily oral emtricitabine and tenofovir disoproxil fumarate …