7 articles
The UK regulator suspended Amgen's drug Tavneos for new patients due to unreliable data, following similar EU actions and a proposed US FDA withdrawal. Existing patients may continue treatment for six
Amgen reported a data breach affecting patient health information and potentially R&D data stored on third-party cloud systems. While manufacturing operations are unaffected, the company is assessing
Amgen agreed to a $74 million settlement regarding a shareholder lawsuit alleging concealment of a $10.7 billion tax liability tied to its Puerto Rico drug manufacturing operations. The company denies
A federal judge blocked Colorado's price cap on Amgen's arthritis drug Enbrel, ruling it violated federal patent law and threatened irreparable harm. The injunction preserves Amgen's pricing strategy
The European Medicines Agency recommended revoking Amgen's marketing authorization for its rare-disease drug Tavneos due to unreliable clinical trial data. This aligns with a similar FDA proposal, pro
Amgen announced a $300 million investment to expand its Puerto Rico biologics manufacturing facility amid potential U.S. tariffs on imported medicines. This expands prior commitments totaling over $1.
The FDA seeks input to expand an AI-driven pilot program enabling real-time data submission for clinical trials, currently testing drugs for lymphoma and lung cancer with partners like AstraZeneca and
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