hcplive.com
Cure8 news brief
FDA Label Change Drops Mandatory TB Screening for Risankizumab - HCPLive
Medications
Risankizumab
IL-23 inhibitor
Regulatory Update
Clinicians
Patients On Biologics
Adult patients
Crohn's disease
Why This Matters
This affects people treated with risankizumab (for psoriasis, psoriatic arthritis, Crohn’s disease, or ulcerative colitis) because TB screening before starting the drug is no longer mandatory and can be individualized by clinicians.
It may speed access and reduce unnecessary testing for many patients, while still allowing testing when risk factors exist.
Who Should Pay Attention
Patients prescribed or considering risankizumab (Skyrizi), dermatologists, gastroenterologists, rheumatologists, clinicians who manage biologic therapy, and patients concerned about TB screening requirements.
Study Snapshot
Story typeResearch news
Evidence typeRegulatory update
Source depthFull source text
What To Know
FDA updated risankizumab (Skyrizi) labeling to make pretreatment tuberculosis evaluation a matter of clinical judgment across all approved indications; the change was announced alongside FDA approval of a subcutaneous induction regimen for Crohn’s disease.
The article summarizes the label revision, references a joint NPF/IPC position statement discouraging routine latent TB testing for IL-17/IL-23 inhibitors in many psoriasis patients, and notes circumstances where testing remains appropriate (eg, patients from TB-endemic areas or those on other immunosuppressants).
Keep In Mind
The label change applies across all indications but does not prohibit testing; clinicians should still follow other drugs’ labels (eg, TNF inhibitors and JAK inhibitors still require screening). The article cites a joint NPF/IPC statement that found limited evidence for TB reactivation risk with IL-17/IL-23 inhibitors.
FDA announced the change concurrently with a Crohn’s disease dosing approval from AbbVie.
Source Details
Review the original publication for the complete reporting, methods, and context.
Publicationhcplive.com
AuthorsTim Smith
Indexed viaGoogle News
Source typeWeb article
PublishedNov 2, 2026, 8:40 PM
Content availableFull source text
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
Digestive and liver disease : official journal of the Italian Society of Gastroenterology and the Italian Association for the Study of the Liver
Adherence to advanced therapies in inflammatory bowel diseases: Real-world rates and predictors of non-adherence.
Adherence affects how well advanced IBD treatments work. Knowing which drug forms and patient factors link to missed doses can help patients and clinicians plan support strategies.
J&J adds to IL-23 options in Crohn's after FDA approval
A newly FDA‑approved IL‑23 drug for Crohn’s may increase treatment options for people with IBD, including an IV and a subcutaneous formulation. The approval could affect switching decisions for patients not responding to...
Lilly nets a second FDA okay for Omvoh, in Crohn's disease
A new FDA approval means another IL-23 option is formally available for people with moderately to severely active Crohn’s disease, including patients whose disease did not respond to other therapies. This could affect...