The New England Journal of Medicine has retracted the pivotal 2021 clinical trial paper for Amgen’s rare-disease drug Tavneos (avacopan). The retraction follows an FDA investigation revealing undisclosed modifications to patient outcome data after the database was locked and unblinded.
Amgen has reported a robust start to the year, with its Q1 2026 financial results exceeding analyst estimates. Total revenue climbed to $8.6 billion, driven by double-digit growth across 16 key brands and a promising expansion of the MariTide obesity program.
Amgen has announced successful topline results from its Phase 3 trial evaluating a subcutaneous formulation of TEPEZZA® for Thyroid Eye Disease, offering a new, convenient delivery method.
A new subgroup analysis from the Phase 3 VESALIUS-CV trial reveals that Amgen’s Repatha reduces the risk of first major cardiovascular events by 31% in high-risk patients without known atherosclerosis.
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…]
