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New STELARA ® (ustekinumab) Long-Term Data Support its Established Safety Profile in Inflammatory Bowel Disease and Durable Efficacy in Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, March 4, 2023 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final pooled long-term safety results for STELARA® (ustekinumab) through five years in adults with moderately to severely active Crohn’s disease (CD) and four years in adults with moderately to severely active ulcerative colitis (UC), as well as final four-year clinical and endoscopic outcomes from the UNIFI long-term extension (LTE) study evaluating the efficacy of STELARA for the treatment of adults with moderately to severely active UC.1,2 These data are a part of Janssen’s 22 oral and poster ...
Source: Johnson and Johnson - March 4, 2023 Category: Pharmaceuticals Tags: Latest News Source Type: news

STELARA ® (ustekinumab) Demonstrated Sustained Symptomatic and Corticosteroid-Free Remission Through Four Years in Adults with Moderately to Severely Active Ulcerative Colitis
SPRING HOUSE, PENNSYLVANIA, October 10, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced final data from the long-term extension (LTE) of the Phase 3 UNIFI study demonstrating efficacy and safety of STELARA® (ustekinumab) through four years of treatment in adult patients with moderately to severely active ulcerative colitis (UC).1 Among all patients who had achieved clinical responsea with STELARA during induction, 64.9 percent were in symptomatic remissionb after 44 weeks of maintenance. At week 200 (four years), this proportion of patients was 55.2 percent; the majority (96.4 percen...
Source: Johnson and Johnson - October 10, 2022 Category: Pharmaceuticals Source Type: news

STELARA ® (ustekinumab) Approved by the U.S. Food and Drug Administration to Treat Pediatric Patients with Active Psoriatic Arthritis
HORSHAM, PENNSYLVANIA, August 1, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has approved STELARA® (ustekinumab) for the treatment of pediatric patients six years of age and older with active psoriatic arthritis (PsA). This rare disease that resembles adult PsA affects five to eight percent of children and adolescents with chronic inflammatory arthritis.*1-7 Two of the four indications for STELARA now include pediatric patients, further expanding its treatment profile since the first approval in 2009 for adults living with moderate...
Source: Johnson and Johnson - August 1, 2022 Category: Pharmaceuticals Tags: Latest News Source Type: news

Janssen Presents Study Results Showing Clinical Efficacy for TREMFYA ® (guselkumab) and Long-Term Safety Profile for STELARA® (ustekinumab) for Patients Living with Inflammatory Bowel Disease at Digestive Disease Week® 2022
SPRING HOUSE, PENNSYLVANIA, May 24, 2022 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced new data from the Phase 2 GALAXI 1 clinical trial of TREMFYA® (guselkumab) in adult patients with moderately to severely active Crohn’s disease (CD), and from three separate long-term pooled analyses of adult patients with ulcerative colitis (UC) and CD treated with STELARA® (ustekinumab).1,2,3,4 These data are being presented as oral and poster presentations and are among 29 Janssen abstracts presented during the Digestive Disease Week® (DDW) meeting taking place in person and virtually in San Di...
Source: Johnson and Johnson - May 24, 2022 Category: Pharmaceuticals Source Type: news

Janssen Reports Positive Topline Week 48 Phase 2 Results for TREMFYA ® (guselkumab) in Adults With Moderately to Severely Active Crohn's Disease
SPRING HOUSE, PENNSYLVANIA, November 17, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced topline results from the Phase 2 GALAXI 1 clinical trial which showed rates of clinical remission (Crohn’s Disease Activity Index [CDAI]<150) previously reported at week 12 increased at week 48 among adults with moderately to severely active Crohn’s disease (CD) treated with TREMFYA® (guselkumab).1 At week 48, 65 percent of patients receiving TREMFYA achieved clinical remission. TREMFYA is under investigation and not currently approved for the treatment of CD in the U.S.2Janssen previously...
Source: Johnson and Johnson - November 17, 2021 Category: Pharmaceuticals Source Type: news

Janssen Submits Application Seeking U.S. FDA Approval of STELARA ® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis
HORSHAM, PENNSYLVANIA, October 8, 2021 – The Janssen Pharmaceutical Companies of Johnson & Johnson today announced the submission of a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) seeking expanded approval of STELARA® (ustekinumab) to treat pediatric patients ages 5 years and older with juvenile psoriatic arthritis (jPsA).The filing is supported by extrapolation of data from nine studies across both adult trials in active PsA and adult and pediatric studies in moderate to severe plaque psoriasis, totaling 3,997 patients evaluated across these closely associated dis...
Source: Johnson and Johnson - October 8, 2021 Category: Pharmaceuticals Tags: Innovation Source Type: news