The FDA has approved a label update cutting Amgen IMDELLTRA monitoring time for the first two doses from 22-24 hours to 6-8 hours, a change aimed at easing treatment burden for ES-SCLC patients in community oncology settings.
Amgen’s Phase 3 DeLLphi-305 trial shows the IMDELLTRA Imfinzi combination delivers a statistically significant, clinically meaningful overall survival benefit as first-line maintenance therapy in extensive-stage small cell lung cancer, alongside gains in progression-free survival and response rate.
Amgen and AstraZeneca announced that TEZSPIRE (tezepelumab-ekko) achieved statistically significant and clinically meaningful results across both co-primary endpoints and all key secondary endpoints in the Phase 3 CROSSING trial in eosinophilic esophagitis, with benefits sustained through week 52.
Amgen data breach headlines have put the biotechnology giant at the center of the healthcare industry’s escalating cybersecurity crisis. Amgen Inc. disclosed on July 31, [Read More…]
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.
