EMA Marketing Authorization of New Drugs in August 2025

Shots: The EMA’s CHMP has granted approvals to 1 Biologic and 3 new chemical entities in August 2025, leading to treatments for patients and advances in the healthcare industry The major highlighted drug was Gilead’s Yeytuo has Secured the EC’s Approval for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV PharmaShots has compiled a list of 4…

ByDipanshu DixitSeptember 16, 2025

NEWS

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots:Approval was based on P-III (PURPOSE 1 & PURPOSE 2) trials of Yeytuo vs Truvada, where PURPOSE 1 showed 0 infections & 100% risk reduction in 2134 women, while PURPOSE 2 depicted 99.9% non-infection rate in 2179 pts (2 acquired HIV), showing superiority to bHIV in both trials; published in The NEJMApproval is…

ByRidhi RastogiAugust 27, 2025

NEWS

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots:The CHMP has recommended approval of the MAA & EU-M4all application of lenacapavir as PrEP for individuals at risk of HIV across all 30 EEA states. It will be marketed in the EU as Yeytuo, if approved by the EC by late 2025Opinion was based on P-III (PURPOSE 1 & PURPOSE 2) trials…

ByRidhi RastogiJuly 28, 2025

NEWS

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

Shots:Merck has initiated P-III (EXPrESSIVE-11) trial to evaluate MK-8527 (QM) vs FTC/TDF for HIV PrEP in ~4,390 individuals at higher risk across 16 countries (enrolment from Aug 2025), & will begin the P-III (EXPrESSIVE-10) trial in ~4,580 women (16-30yrs.) in sub-Saharan Africa, with enrolment starting in the next few mos.Decision to initiate P-III…

ByDipanshu DixitJuly 15, 2025

NEWS

Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA

Shots:The US FDA accepted Merck’s NDA for once-daily oral doravirine/islatravir (DOR/ISL) for virologically suppressed HIV-1 adults; PDUFA target action date: Apr 28, 2026DOR/ISL showed non-inferiority to bART in open-label P-III MK-8591A-051 and to BIC/FTC/TAF (50mg/200mg/25mg) in P-III MK-8591A-052 at Week 48; the safety profile was generally comparable in the P-III MK-8591A-051 studyThe…

ByDipanshu DixitJuly 11, 2025

NEWS

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Shots:FDA has approved Yeztugo for PrEP in individuals (≥35kgs) at risk of HIV. MAA & EU-M4all filing are under EMA review, with ongoing reviews in Australia, Brazil, Canada, & South Africa; further filings are planned in Argentina, Mexico, & PeruApproval was based on P-III (PURPOSE 1 & 2) trials assessing Yeztugo (SC; twice…

ByRidhi RastogiJune 19, 2025

NEWS

Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots:The EMA has accepted MAA & EU-M4all as well as granted priority review to lenacapavir (HIV-1 capsid inhibitor) for PrEP in humans at risk of HIV; MAA will be applicable in 30 EEA states (incl. Norway, Iceland & Liechtenstein) MAA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC;…

ByRidhi RastogiFebruary 25, 2025

NEWS

Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Shots:The US FDA has accepted & granted priority review to the NDA of lenacapavir (HIV-1 capsid inhibitor) for PreP in individuals at risk of HIV (PDUFA: Jun 19, 2025); MAA & EU-M4all application has been filed to the EMA NDA was based on P-III (PURPOSE 1 & PURPOSE 2) trials assessing lenacapavir (SC; twice…

ByRidhi RastogiFebruary 19, 2025

NEWS

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

Shots:ViiV Healthcare (owned by GSK with Pfizer & Shionogi as shareholders) has received EC’s approval for Vocabria (cabotegravir) combined with J&J’s Rekambys (rilpivirine) to treat HIV-1 in virologically suppressed adolescents (≥12yrs. & ≥35kg), following CHMP opinion in Dec 2024 MAA was based on 24wks. data from ongoing P-I/II (MOCHA) trial evaluating the safety,…

ByDipanshu DixitJanuary 31, 2025

VIEWPOINTS

ViiV at IDWeek 2024: Dr. Harmony Garges in an Illuminating Dialogue Exchange with PharmaShots

Shots: Recently at IDWeek 2024, ViiV Healthcare presented data from two real-world studies on Apretude, a long-acting injectable (LAI) for HIV pre-exposure prophylaxis. Dr. Harmony Garges, Chief Medical Officer at ViiV, shared insights from the presentations. The Opera cohort study found Apretude to be 99.7% effective in preventing HIV among participants. Additionally, the Trio Health…

BySaurabh ChaubeyDecember 16, 2024

EMA Marketing Authorization of New Drugs in August 2025

Gilead Reports the EC’s Approval of Yeytuo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Gilead Reports the CHMP’s Positive Opinion on Lenacapavir for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Merck Advances MK-8527 in P-III (EXPrESSIVE) Trials to Prevent HIV in Individuals at Risk

Merck NDA for Investigational HIV-1 Two-Drug Regimen DOR/ISL Accepted by US FDA

Gilead Reports the US FDA’s Approval of Yeztugo (Lenacapavir) for Pre-Exposure Prophylaxis (PrEP) to Prevent HIV in Individuals at Risk

Gilead Reports the EMA’s MAA and EU-M4all Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

Gilead Reports US FDA’s NDA Acceptance of Lenacapavir for Pre-Exposure Prophylaxis (PreP) to Prevent HIV in Individuals at Risk

ViiV Healthcare Reports the EC’s Approval of Vocabria + Rekambys to Treat HIV

ViiV at IDWeek 2024: Dr. Harmony Garges in an Illuminating Dialogue Exchange with PharmaShots

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