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✗ Close categories

  • Less Frequent Checkpoint Inhibitor Dosing Raises Survival Concern in Responding Patients

    via Pharmacy Practice News
    Less Frequent Checkpoint Inhibitor Dosing Raises Survival Concern in Responding Patients
    Originally published by our sister publication Clinical Oncology NewsBy Jennifer KulpaDurable responses to immune checkpoint inhibitors (ICIs), along with target engagement that persists beyond standard dosing intervals, have raised the possibility of dosing these agents less often in patients who respond. However, in the phase 3 MOIO trial, extending the dosing interval in responders with advanced solid tumors did not preserve progression-free survival (PFS), offered no meaningful safety advant
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  • Form 483 Trends, Reading the Investigator, and Taking Control

    via Pharmacy Practice News
    Form 483 Trends, Reading the Investigator, and Taking Control
    By Gina ShawIn March 2026, the FDA issued new draft guidance spelling out how drug manufacturers, including 503B outsourcing facilities, should respond to Form 483 inspection observations. The comment period closed on May 8, with industry stakeholders generally welcoming clearer expectations while seeking changes to provisions they said could make the agency’s long-standing 15-business-day response window difficult to meet. The guidance remained in draft form as of late September.Against that
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