The European Commission has granted approval for Amgen’s UPLIZNA® (inebilizumab) as an add-on treatment for adults with generalized myasthenia gravis making it the first and only CD19-targeted therapy authorized in Europe for this rare, debilitating autoimmune muscle disease. The approval is backed by pivotal Phase 3 data from the landmark MINT trial.
Amgen closes 2025 with record revenues of $36.8 billion, driven by double-digit volume growth. Looking ahead to 2026, the biotech giant focuses on the global commercialization of Imdelltra and high-stakes data readouts for its obesity candidate, MariTide.
In its first major move of 2026, Amgen (NASDAQ: AMGN) has announced the acquisition of Dark Blue Therapeutics Ltd., a privately held U.K. biotech specializing [Read More…]
The FDA has approved Amgen’s UPLIZNA for adults with generalized myasthenia gravis (gMG) who are anti-AChR or anti-MuSK antibody positive. UPLIZNA is the first and only CD19-targeted B-cell therapy approved for this indication, offering a convenient dosing schedule of just two maintenance doses per year following the initial loading regimen. The approval is based on strong efficacy data from the Phase 3 MINT trial.
Amgen’s groundbreaking drug IMDELLTRA has secured full FDA approval for extensive stage SCLC based on compelling Phase 3 data. It reduced the risk of death by 40%, offering a major advance for relapsed patients.
Amgen‘s cholesterol-lowering medication Repatha® (evolocumab) dramatically reduces the risk of a first major adverse cardiovascular event (MACE) in high-risk patients by 25%, according to groundbreaking [Read More…]
Amgen announced strong third-quarter 2025 financial results, with total revenues increasing 12% to $9.6 billion, driven by a 14% surge in product sales volume. While GAAP EPS rose 14% to $5.93, non-GAAP EPS saw a modest 1% increase due to a 31% jump in R&D spending to advance its late-stage pipeline, including the obesity drug MariTide.
Amgen announced that its landmark Phase 3 VESALIUS-CV clinical trial for Repatha® (evolocumab) met its primary endpoints, demonstrating a significant reduction in the risk of major adverse cardiovascular events (MACE) in high-risk individuals without a prior history of heart attack or stroke. The study, which enrolled over 12,000 patients, positions Repatha as the first and only PCSK9 inhibitor to show such a benefit in this primary prevention setting, offering a new hope for patients at high risk for cardiovascular disease.
Amgen and Kyowa Kirin announced positive top-line results from the ASCEND Phase 3 long-term study for rocatinlimab, an investigational treatment for adults and adolescents with moderate to severe atopic dermatitis. The study demonstrated a continued therapeutic benefit and a consistent safety profile, showing sustained improvements in skin clearance and itch reduction at one year.
Biotechnology giant Amgen is investing over $600 million to build a new research and development hub in Southern California. The cutting-edge facility will bring together top scientific minds to advance the creation of new medicines and is expected to generate hundreds of jobs, reinforcing the company’s commitment to U.S.-based innovation.
