October 24, 2025
Clinical Updates
Gazyva® (obinutuzumab) – New indication
October 19, 2025 - Genentech announced the FDA approval of Gazyva (obinutuzumab), for the treatment of adult patients with active lupus nephritis who are receiving standard therapy.
Clinical Updates
Rybelsus® (semaglutide) – New indication
October 17, 2025 - Novo Nordisk announced the FDA approval of Rybelsus (semaglutide), to reduce the risk of major adverse cardiovascular events (MACE) (cardiovascular death, non-fatal myocardial infarction or non-fatal stroke) in adults with type 2 diabetes mellitus (T2DM) who are at high risk for these events.
Clinical Updates
Rytary® (carbidopa/levodopa) – First-time authorized brand alternative
October 20, 2025 - Zydus launched an authorized brand alternative of Amneal’s Rytary (carbidopa/levodopa) extended-release capsules.
Clinical Updates
Tezspire® (tezepelumab) – New indication
October 17, 2025 - AstraZeneca and Amgen announced the FDA approval of Tezspire (tezepelumab), for the add-on maintenance treatment of adult and pediatric patients aged 12 years and older with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
Clinical Updates
Xeljanz® (tofacitinib) – Expanded indication
October 16, 2025 - The FDA approved Pfizer’s Xeljanz (tofacitinib), for the treatment of adult and pediatric patients 2 years of age and older with active psoriatic arthritis (PsA), who have had an inadequate response or intolerance to one or more TNF blockers.
New Generics
Ravicti® (glycerol phenylbutyrate) – First-time generic
October 20, 2025 - Endo launched an AA-rated generic version of Amgen’s Ravicti (glycerol phenylbutyrate) oral solution.