Policy and access topics
Regulatory update articles covering approvals, label changes, safety notices, and policy decisions relevant to IBD care.
34 articles
A new national approval means guselkumab (TREMFYA) may soon be an available treatment option for people with Crohn’s disease or ulcerative colitis in Egypt, potentially expanding choices for moderate-to-severe disease....
This could expand an approved, gut-targeted biologic (vedolizumab/ENTYVIO) to children as young as 2 with UC or Crohn’s disease, addressing a pediatric treatment gap if the FDA approves the sBLA. Families and clinicians...
Cure8 found this source from tipranks.com, but the page could not be read reliably yet. It is tagged for Crohn's disease, Inflammatory bowel disease, and Ustekinumab. Open the original article for the full details.
A subcutaneous induction option for SKYRIZI could let people with Crohn’s start and continue treatment with injections instead of beginning with an IV infusion, which may affect convenience, time in clinic, and infusion...
Based on the title and source metadata, this appears to be a regulatory update related to Ustekinumab, IL-12/23 inhibitor, and Medications. The original article is from msn.com.
An interchangeable biosimilar to ustekinumab could expand access and lower costs for people with Crohn’s disease and ulcerative colitis who use Stelara. Pharmacists may be able to substitute the biosimilar for the...
An FDA interchangeability approval for a biosimilar to ustekinumab could make a lower-cost alternative more available for people with Crohn’s disease or ulcerative colitis who use Stelara. It’s primarily a regulatory and...
Formulary listings for Yesintek (ustekinumab biosimilar) could make an established IBD treatment more affordable and accessible for people with Crohn’s disease or ulcerative colitis. Wider payer coverage may affect which...
Based on the title and source metadata, this appears to be a regulatory update related to Crohn's disease, Inflammatory bowel disease, and Guselkumab. The original article is from firstwordpharma.com.
Regulatory approval means ustekinumab (Stelara) can now be prescribed in the EU for some children with moderate‑to‑severe Crohn’s disease who haven’t responded to other treatments. This expands treatment options for...
A new EC approval makes ustekinumab an approved treatment option for children and adolescents (≥40 kg) with moderate–severe Crohn’s disease, potentially expanding choices for patients who haven’t responded to other...
A CHMP recommendation is a major regulatory step toward EU approval — that could mean a new biologic option (guselkumab/Tremfya) for adults with moderate–severe Crohn’s disease, including people who haven’t responded to...
This FDA approval adds another biologic option (an IL-23 inhibitor) for adults with moderate-to-severe Crohn’s disease, including both self-administered subcutaneous dosing and an IV induction route. New options may...
Based on the title and source metadata, this appears to be a regulatory update related to Crohn's disease, Inflammatory bowel disease, and Guselkumab. The original article is from firstwordpharma.com.
This approval adds an FDA-cleared IL-23 biologic (Tremfya) as a treatment option for adults with moderately to severely active Crohn’s disease, which may affect treatment choices. It also comes as multiple biosimilars to...
An FDA approval means a new biologic option (guselkumab/Tremfya) is available for adults with moderately to severely active Crohn’s disease and may change prescribing choices. The approval highlights a dosing flexibility...
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...
A newly FDA-approved biologic (guselkumab/Tremfya) offers another treatment option for adults with moderate to severe Crohn’s disease, including both IV and SC induction choices. This could matter for patients who have...
An FDA approval means TREMFYA is now an additional, officially authorized treatment option for adults with moderately to severely active Crohn's disease. The drug offers both IV and SC induction choices and established...
Cure8 found this source from fiercepharma.com, but the page could not be read reliably yet. It is tagged for Crohn's disease, Inflammatory bowel disease, and Guselkumab. Open the original article for the full details.
A CE mark under the EU IVDR means a new non-invasive test aimed at identifying dietary triggers for people with UC or Crohn’s may become available in Europe. Tests like this could affect how some patients and clinicians...
A new CE-marked food-intolerance diagnostic could give people with Crohn’s or UC a non-invasive tool to explore dietary triggers alongside clinical care. Regulatory certification means the products met EU safety and...
A new FDA‑approved biosimilar to ustekinumab is now available in the U.S., which may increase treatment options and lower out‑of‑pocket costs for people with Crohn’s disease or ulcerative colitis. The article highlights...
A new FDA‑approved ustekinumab biosimilar (YESINTEK) is now available in the US for Crohn’s disease and ulcerative colitis, which may increase treatment options and lower costs. Coverage and copay support at launch could...
Cure8 could only read part of this source from devdiscourse.com, so this card uses cautious topic tags instead of a full summary. It is tagged for Crohn's disease, Ulcerative colitis, and Ustekinumab.
A new ustekinumab biosimilar (SELARSDI) is now available in the U.S. for Crohn’s disease and ulcerative colitis, which may expand treatment options and affect access or cost for patients on biologic therapy.
A newly approved biologic, Omvoh (mirikizumab), gives another FDA‑approved treatment option for adults with moderate to severe Crohn’s disease and adds to Lilly’s role in IBD care.
This gives adults with moderately to severely active Crohn’s disease another FDA‑approved biologic option, including for people who did not respond to or could not tolerate other therapies.
A new FDA approval means another biologic option for people with moderately to severely active Crohn’s disease, including patients who have failed or not tolerated prior therapies.
An FDA approval means another biologic option is available for Crohn’s disease, which could affect treatment choices and insurance coverage. The approval also signals pharma competition and pipeline activity that may...
An FDA approval means Omvoh is now an available biologic option for adults with Crohn’s disease, potentially expanding treatment choices. Payer decisions mentioned in the article could affect how quickly patients can...
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...
FDA approval means mirikizumab (Omvoh) is now an available biologic option in the US for adults with moderately to severely active Crohn’s disease, especially for people who did not respond to standard treatments. It may...
A newly FDA-approved biologic (Omvoh/mirikizumab) gives adults with moderately to severely active Crohn's disease another targeted treatment option. It's the same IL-23–targeting drug already approved for ulcerative...
