Amgen secures FDA approval for reduced monitoring time for IMDELLTRA
The updated prescribing information lowers initial infusion observation from 22 hours to 6-8 hours, facilitating broader access in community oncology settings.
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Multinational biopharmaceutical company
amgen.comLast updated
In short: Amgen raised its 2026 guidance following strong sales and positive data for Repatha and Imdelltra, despite facing regulatory woes for Tavneos.
The updated prescribing information lowers initial infusion observation from 22 hours to 6-8 hours, facilitating broader access in community oncology settings.
The phase 3 DeLLphi-305 trial met primary and secondary endpoints for overall survival, progression-free survival, and objective response rate compared to standard care.
Clinical trial results show a 20% reduction in all-cause mortality among over 12,000 participants receiving treatment alongside statins.
The ranking evaluates AI readiness, innovation, talent, finance, resilience, and agility, highlighting Amgen's top-tier scores among all evaluated firms.
Bristol Myers Squibb and Ono Pharmaceutical have sued Amgen in Delaware federal court, seeking to block Amgen's proposed U.S. biosimilar of their blockbuster cancer immunotherapy...
Amgen (NASDAQ:AMGN) outlined its growth priorities, late-stage pipeline progress and capital-allocation framework during a Morgan Stanley conference, as newly appointed Chief Financial Officer Thomas Dittrich...
It’s unlikely a lipid-lowering agent can directly reduce infection or malignancy, but some argue it could stop a domino effect.
Topline Phase III results for DLL3-inhibiting bispecific Imdelltra plus AstraZeneca’s Imfinzi showed improved survival as a ...
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