Gilead’s Bixlenvo Secures US FDA Approval for Virologically Suppressed Adults With HIV

Shots: The US FDA has approved Bixlenvo (bictegravir 75mg/lenacapavir 50mg) for the treatment of HIV in adults who are virologically suppressed Approval was based on the P-III (ARTISTRY-1 & ARTISTRY-2) trials, assessing Bixlenvo (QD, PO) in adults with HIV who are virologically suppressed, incl. those who switched from complex multi-tablet regimens or from Biktarvy In…

ByRidhi RastogiAugust 31, 2026

NEWS

Tolerance Bio Licenses Efineptakin Alfa from NeoImmuneTech to Advance Thymic Function and Immune Resilience Programs

Shots: Tolerance Bio entered into an exclusive license agreement with NeoImmuneTech for the development and commercialization of efineptakin alfa (NT-I7), for certain thymus-related indications in the Americas and Europe. The company also plans to initiate P-II studies evaluating the therapy for enhancement of thymic function Under the agreement, Tolerance Bio will advance efineptakin alfa alongside…

ByPrince GiriAugust 20, 2026

NEWS

ViiV Healthcare Reports P-IIIb (VOGUE) Trial Data on Dovato for Treatment-Naïve Adults with HIV

Shots: ViiV has reported P-IIIb (VOGUE) study data assessing Dovato (DTG/3TC; n=254) vs Biktarvy (BIC/FTC/TAF; n=255) in 509 treatment-naïve adults living with HIV-1, where treatment was initiated before the availability of baseline resistance testing results At baseline, 47% pts had HIV-1 RNA ≥100,000 copies/mL, 16% had ≥500,000 copies/mL, & 16% had CD4+ counts <200 cells/mm³. At Wk.…

ByRidhi RastogiJuly 28, 2026

NEWS

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

Shots: The US FDA has accepted sNDA of Yeztugo (300mg, QW, PO) as a pre-exposure prophylaxis therapy for the prevention of HIV (PDUFA: Feb 02, 2027) sNDA was supported by the P-III (PURPOSE 1 & PURPOSE 2) trials of Yeztugo, which demonstrated high efficacy across diverse global populations, incl. cisgender women, cisgender men & gender-diverse…

ByRidhi RastogiJune 16, 2026

INSIGHTS+

The US FDA New Drug Approvals in April 2026

Shots: Approval activity continued strongly into April 2026, with the US FDA authorizing two significant therapies across metabolic disease and infectious disease, reinforcing the agency’s focus on chronic disease management, long-term treatment innovation, and broader patient access. Two notable therapies achieved regulatory clearance: Eli Lilly’s Foundayo for weight loss in obese or overweight adults with weight-related conditions,…

ByDipanshu DixitMay 12, 2026

NEWS

ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

Shots: ViiV Healthcare has reported 12mos. interim data from P-IIb (EMBRACE) trial assessing lotivibart (IV or SC, Q4M) + cabotegravir (CAB LA; IM, QM) vs SoC for the treatment of HIV lotivibart + cabotegravir maintained viral suppression in 94% of lotivibart IV & 82% of SC recipients vs 88%, with confirmed virologic failure in 4%…

ByRidhi RastogiFebruary 26, 2026

NEWS

ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients

Shots: The P-III (LATITUDE) trial assessed Cabenuva (cabotegravir + rilpivirine) in 453 adults facing adherence challenges, where 306 virally suppressed pts were randomized to Cabenuva (Q4W; n=152) or ART (QD, PO; n=154), with results published in The NEJM At 48wks., Cabenuva reduced the cumulative risk of regimen failure (1EP) to 22.8% vs 41.2%, with fewer virologic failures…

ByRidhi RastogiFebruary 19, 2026

NEWS

GSK and Shionogi Restructure ViiV Healthcare Ownership as Pfizer Exits

Shots: GSK & Shionogi, together with Pfizer, have agreed to replace Pfizer’s 11.7% economic interest in ViiV Healthcare with an investment by Shionogi, reshaping the ownership structure of ViiV Healthcare As per the deal, ViiV Healthcare will issue new shares to Shionogi for $2.125B, cancel Pfizer’s stake, pay Pfizer $1.875B, & distribute a $0.25B special…

ByRidhi RastogiJanuary 21, 2026

INSIGHTS+

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 NEJM Approval is…

ByRidhi RastogiAugust 27, 2025

Gilead’s Bixlenvo Secures US FDA Approval for Virologically Suppressed Adults With HIV

Tolerance Bio Licenses Efineptakin Alfa from NeoImmuneTech to Advance Thymic Function and Immune Resilience Programs

ViiV Healthcare Reports P-IIIb (VOGUE) Trial Data on Dovato for Treatment-Naïve Adults with HIV

The US FDA Accepts Gilead’s Once-Weekly Oral Yeztugo for Review as a PrEP Therapy for HIV Prevention

The US FDA New Drug Approvals in April 2026

ViiV Healthcare Reports P-IIb (EMBRACE) Trial Data on Lotivibart + Cabotegravir for HIV Treatment

ViiV Healthcare Reports P-III (LATITUDE) Trial of Cabenuva in Adherence-Challenged HIV Patients

GSK and Shionogi Restructure ViiV Healthcare Ownership as Pfizer Exits

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

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