twice-yearly – Talk Bio

FDA broadens label for Amgen’s Uplizna as it enters rare disease competition

1 day ago talkbio0Tagged AChR-positive, amgen, Approved, disease market, dosing, expansion, gMG, IgG4-Related Disease, inebilizumab, Infrequent, Labels (device), MINT trial, MuSK-positive, Myasthenia Gravis, Generalized, Neuromyelitis Optica, twice-yearly, United States Food and Drug Administration, Uplizna

Uplizna; inebilizumab; Amgen; FDA approval; label expansion; generalized myasthenia gravis; gMG; AChR-positive; MuSK-positive; neuromyelitis optica spectrum disorder; NMOSD; IgG4-related disease; rare disease market; MINT trial; twice-yearly dosing

Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Paving Way for Regulatory Filings

1 year ago talkbio0Tagged Gilead Sciences, HIV prevention, Lenacapavir, PREP gene, regulatory, twice-yearly

Gilead Sciences, Lenacapavir, HIV Prevention, Twice-Yearly PrEP, Regulatory Filings, PURPOSE 2 Trial

Gilead’s Twice-Yearly Lenacapavir Shows 96% HIV Risk Reduction, Eyes 2025 Launch for HIV Prevention

1 year ago talkbio0Tagged HIV prevention, Injection of therapeutic agent, launch, Lenacapavir, PREP gene, regulatory, trials, twice-yearly

Lenacapavir, HIV Prevention, Twice-Yearly Injection, Gilead Sciences, PrEP, PURPOSE 1 and 2 Trials, Regulatory Filings, 2025 Launch