Policy and access topics
Regulatory update articles covering approvals, label changes, safety notices, and policy decisions relevant to IBD care.
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An FDA approval of an autoinjector for ustekinumab may make self‑injection easier and more convenient for people with Crohn’s disease or ulcerative colitis who use this biologic. Changes in delivery format can also...
This update is important because tofacitinib is a JAK inhibitor approved for adults with moderately to severely active ulcerative colitis after inadequate response to TNF blockers, and the label includes major safety...
Cure8 could only read part of this source from PubMed Central, so this card uses cautious topic tags instead of a full summary. It is tagged for Crohn's disease, Natalizumab, and Biosimilars.
FDA drug-label updates change how a medicine should be used and monitored. For people with ulcerative colitis and other immune-mediated diseases, this label highlights safety risks and limits on combining tofacitinib...
This is an updated FDA drug label for tofacitinib, a JAK inhibitor that is approved for ulcerative colitis and other immune conditions.
If approved, a vedolizumab biosimilar could increase treatment options and potentially lower costs or improve access to an established biologic used for moderate-to-severe Crohn’s disease and ulcerative colitis....
Regulatory review starts a formal approval process that could lead to a lower-cost biosimilar alternative to Entyvio (vedolizumab), potentially improving access to a biologic used in Crohn’s disease and ulcerative...
A vedolizumab biosimilar could increase access to an important biologic treatment for people with moderate‑to‑severe UC and Crohn’s disease by offering a potentially lower‑cost alternative. Regulatory review by the FDA...
Accepted applications for a vedolizumab biosimilar could lead to another treatment option for adults with moderate‑to‑severe ulcerative colitis and Crohn’s disease and may improve access or affordability if approved.
If approved, a vedolizumab biosimilar could increase access to an established IBD biologic by offering a lower-cost alternative, potentially reducing barriers to starting or continuing treatment for people with...
Cure8 could only read part of this source from newsbytesapp.com, so this card uses cautious topic tags instead of a full summary. It is tagged for Crohn's disease, Ulcerative colitis, and Inflammatory bowel disease.
This DailyMed/FDA label update affects adults with moderately to severely active ulcerative colitis because it states approved use of tofacitinib extended‑release and highlights important safety warnings and recommended...
Label updates for INFLECTRA affect people with Crohn’s disease and ulcerative colitis because they summarize approved uses, dosing, and safety warnings for a commonly used anti-TNF biologic/biosimilar. The label...
An FDA DailyMed label update directly affects prescribing information and safety warnings for tofacitinib, a drug used in ulcerative colitis and other immune-mediated diseases. Patients and clinicians should be aware of...
A new DailyMed label update for RINVOQ (upadacitinib) outlines FDA-approved uses that include Crohn’s disease and ulcerative colitis and highlights important safety warnings relevant to people with IBD. Patients and...
The FDA label update for tofacitinib lists ulcerative colitis among approved uses and highlights serious safety warnings that are directly relevant to people with IBD considering or taking this oral JAK inhibitor.
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...
