FDAsafety guidance65% confidence
Janus Kinase (JAK) inhibitors: Drug Safety Communication - FDA Requires Warnings about Increased Risk of Serious Heart-related Events, Cancer, Blood Clots, and Death
Source: FDA
Why This Matters
Why this matters: provides agency context on safety guidance that may shape timing or evidence expectations for Regeneron.
Regulatory Analysis
FDA is requiring revisions to the Boxed Warning, FDA’s most prominent warning, for Xeljanz/Xeljanz XR, Olumiant, and Rinvoq to include information about the risks of serious heart-related events, cancer, blood clots, and death.
Supporting Context
- Therapeutic area
- Oncology · Skin Cancer
- Sub-indication
- General
Related signal: Phase III Trial Evaluates Cemiplimab with Surgery for Advanced Skin Cancer
Source
FDA document
View source