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FDA extends approval of Tivicay to treat newborns with HIV — Warptech Lab News

FDA extends approval of Tivicay to treat newborns with HIV

The FDA has extended its approval of dolutegravir tablets for oral suspension to treat newborns with HIV. Dolutegravir tablets (Tivicay, ViiV Healthcare) and dolutegravir tablets for oral suspension (Tivicay PD, ViiV) were previously approved for adults and infants aged at least 4 weeks and weighing 3 kg or more.

martedì 25 agosto 2026 New tab

294 words~1 min read

August 25, 2026

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Other newsrooms on this story

· 10 sources

Full timeline →

medpagetoday.com·Aug 26, 2026 · 4 g fa
FDA Expands Label of Oral HIV Drug to Newborns
morningstar.com·Aug 26, 2026 · 4 g fa
U.S. FDA approves ViiV Healthcare’s Tivicay PD, helping close a critical HIV treatment gap for young children
endpoints.news·Aug 26, 2026 · 4 g fa
Haisco grants license to Sentivera; ViiV's HIV treatment OK'd for newborns
endpoints.news·Aug 28, 2026 · 3 g fa
Gilead gets another HIV treatment approval, extending lenacapavir's dominance
morningstar.com·Aug 28, 2026 · 3 g fa
U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV, Including Those on Complex Regimens
qz.com·Aug 28, 2026 · 2 g fa
FDA approves Gilead's Bixlenvo HIV pill for complex regimens
medpagetoday.com·Aug 28, 2026 · 2 g fa
Bictegravir-Lenacapavir Combo Pill Earns FDA Approval in Suppressed HIV
cnbc.com·Aug 27, 2026 · 3 g fa
FDA approves daily HIV pill from Gilead designed to simplify treatment for some patients
fiercepharma.com·Aug 27, 2026 · 3 g fa
Gilead christens Bixlenvo with FDA nod for new HIV treatment combo tablet
newsbytesapp.com·Aug 28, 2026 · 3 g fa
FDA approves new once-daily pill to simplify HIV treatment

Related reading

medpagetoday.com

FDA Expands Label of Oral HIV Drug to Newborns

Dolutegravir is already approved as combination therapy in adults and older children

medpagetoday.com·4 g fa

morningstar.com

U.S. FDA approves ViiV Healthcare’s Tivicay PD, helping close a critical HIV…

U.S. FDA approves ViiV Healthcare’s Tivicay PD, helping close a critical HIV treatment gap for young children

morningstar.com·4 g fa

Haisco grants license to Sentivera; ViiV's HIV treatment OK'd for newborns

Haisco licenses inflammatory drug to Sentivera for $40M upfront, $36M stock, $1.46B milestones; FDA OKs ViiV's dolutegravir for…

endpoints.news·4 g fa

FDA approves smallest single-pill HIV regimen, Bixlenvo

The FDA has approved Bixlenvo, the first single-pill daily HIV therapy for adults being successfully treated on more complex…

healio.com·3 g fa

Gilead gets another HIV treatment approval, extending lenacapavir's dominance

Gilead's FDA-approved Bixlenvo (BIC/LEN), a grain-of-rice-sized once-daily HIV pill, targets virologically suppressed patients &…

endpoints.news·3 g fa

morningstar.com

U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for…

U.S. FDA Approves Gilead’s Bixlenvo™, a New Once-Daily Single Tablet Option for Virologically Suppressed Adults With HIV,…

morningstar.com·3 g fa