FDA approves shorter monitoring time for Amgen’s Imdelltra first two doses - AMGN News | RalliesFDA approves shorter monitoring time for Amgen’s Imdelltra first two doses
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AMGN• FDA clears shorter post-infusion monitoring for Imdelltra
- FDA cleared a label update for Amgen’s IMDELLTRA that cuts post-infusion monitoring for the first two doses to 6-8 hours.
- Prior guidance called for 22-24 hours of monitoring, raising the likelihood of broader uptake in community oncology settings.
- Follow-up assessments, including vital signs, are now required the day after each of the first two doses.
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