Nasdaq

TREMFYA® (guselkumab) demonstrates impressive results across biologic-naïve and biologic-refractory patients in Crohn's disease and ulcerative colitis

TREMFYA® is the only IL-23 inhibitor to demonstrate superiority to ustekinumab in the overall population of patients with Crohn's disease, inclusive of those who are biologic-naïve and ...
Morningstar

TREMFYA® (guselkumab) achieves U.S. approval for subcutaneous induction in adults with ulcerative colitis, now the first and only IL-23 inhibitor with a fully subcutaneous regimen

TREMFYA® offers the flexibility of self-administration from the start of treatment, building on the prior approval of subcutaneous induction in Crohn's disease TREMFYA® achieved significant rates of ...
Nasdaq

TREMFYA® (guselkumab) receives U.S. FDA approval for adults with moderately to severely active ulcerative colitis, strengthening Johnson & Johnson's leadership in inflammatory ...

The first and only dual-acting interleukin-23 inhibitor approved in active ulcerative colitis, TREMFYA® showed highly statistically significant rates of endoscopic remission at one year in the pivotal ...
Seeking Alpha

TREMFYA® (guselkumab), the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn's disease at two years

*The as observed analysis set included participants who entered the LTE, received ≥1 partial or complete study drug dose during the LTE, remained on treatment, and had data available at Week 96; ...
Daily Local News

New Phase 3 Data Show First-in-Class TREMFYA(R) (guselkumab) Achieved Complete Skin Clearance and Favorable Joint Efficacy in Adult Patients with Active Psoriatic Arthritis ...

In addition, results showed 56 percent of TREMFYA q4w patients and 55 percent of TREMFYA q8w patients achieved at least 50 percent improvement in ACR score (utilizing NRI). 2 Among patients who had ...
Morningstar

U.S. FDA approves TREMFYA® (guselkumab) for the treatment of pediatric plaque psoriasis and active psoriatic arthritis, marking a first and only approval for an IL-23 inhibitor

TREMFYA® is now approved for pediatric patients living with moderate to severe plaque psoriasis, who are candidates for systemic therapy or phototherapy, and active psoriatic arthritis in children six ...
Yahoo

J&J eyes FDA approval for injection-based Tremfya in ulcerative colitis

Johnson & Johnson (J&J) Innovation Medicine has submitted a request to the US Food and Drug Administration (FDA) to approve a new way of starting treatment with its drug Tremfya (guselkumab) for ...
manilatimes

TREMFYA (guselkumab) receives positive CHMP opinion for subcutaneous induction regimen in ulcerative colitis, a first for an IL-23 inhibitor

Guselkumab has the potential to become the first IL-23 inhibitor to offer both subcutaneous and intravenous induction options inulcerative colitis, providing flexibility and simplicity for patients ...
Monthly Prescribing Reference

Tremfya One-Press Patient-Controlled Injector Approved for Patients With Moderate-to-Severe Plaque Psoriasis

The FDA has approved Tremfya (guselkumab; Janssen) One-Press, a single-dose patient-controlled injector for the treatment of moderate-to-severe plaque psoriasis in adults. The Food and Drug ...
PharmiWeb

European Commission approves TREMFYA® (guselkumab) for the treatment of children with plaque psoriasis, marking the first paediatric indication for an IL-23 inhibitor

Guselkumab has received approval for moderate to severe plaque psoriasis in children and adolescents from the age of 6 years who are candidates for systemic therapy.1The decision is supported by the ...
Pharmabiz

J&J announces Tremfya, the first and only IL-23 inhibitor with a fully subcutaneous treatment regimen, demonstrates durable remission in Crohn's disease at two years

Johnson & Johnson (J&J) announced new 96-week data from the long-term extensions (LTE) of the phase 3 GRAVITI, GALAXI 2 and GALAXI 3 studies, which show the durability of Tremfya (guselkumab) in ...