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Janssen Submits Application Seeking U.S. FDA Approval of STELARA® (ustekinumab) for the Treatment of Pediatric Patients With Juvenile Psoriatic Arthritis
Application utilizes extrapolation-based strategy across existing breadth of STELARA data in patients living with this chronic inflammatory disease
Janssen Announces Novel Mechanism of Action that Shows Promise Against Dengue in Data Published in Nature
Early-stage research suggests potential to prevent and treat all dengue serotypes With no treatments available, dengue infects up to 400 million people each year and the pace of outbreaks is increasing.[1] This research builds on Johnson & Johnson’s work to advance science against emerging and entrenched global public health threats
Johnson & Johnson Announces Submission of Emergency Use Authorization Amendment to the U.S. FDA to Support Booster of its Single-Shot COVID-19 Vaccine
Submission includes data showing a booster increased protection to 94 percent against moderate to severe/critical COVID-19 in the U.S. Substantial increase in immune response when booster was given at six months The Company’s single-shot vaccine has demonstrated strong and long-lasting protection and durable immune responses in clinical studies
New Analysis Presented by Janssen at United European Gastroenterology Week (UEGW) Demonstrates Long-Term Safety Profile for STELARA® (ustekinumab) in Older Patients Across Approved Indications
First examination of safety events in the 60 and over sub-population across STELARA indications, including inflammatory bowel disease where relatively little biologics safety data exists, are generally consistent with placebo Janssen presents 13 abstracts, including four oral presentations and two late breakers
Janssen Announces Phase 2b Data Demonstrating its Investigational RSV Adult Vaccine Provided 80% Protection against Lower Respiratory Infections in Older Adults
Phase 2b CYPRESS study met all primary and secondary endpoints
Janssen Announces Start of Phase 3 Trial for Investigational Respiratory Syncytial Virus (RSV) Vaccine in Older Adults
Positive Phase 2b data supporting further evaluation will be presented at IDWeek 2021
New Phase 3 Data Suggest Positive Effect and Show Similar Safety with XARELTO® (rivaroxaban) Compared to Aspirin in Pediatric Fontan Procedure Patients at Risk for Blood Clots and Blood Clot-Related Events
Pivotal UNIVERSE study published in the Journal of the American Heart Association Data included in recent New Drug Application submitted to FDA for two pediatric indications
Johnson & Johnson Announces Real-World Evidence and Phase 3 Data Confirming Strong and Long-Lasting Protection of Single-Shot COVID-19 Vaccine in the U.S.
Additional data show a booster increases protection 94 percent protection in the U.S. with booster given at two months Four-fold increase in antibodies when given at two months 12-fold increase in antibodies when booster given at six months
Janssen Presents Results from Phase 1b/2 NORSE Study in Patients with Metastatic or Locally Advanced Urothelial Carcinoma Treated with BALVERSA® (erdafitinib) in Combination with Cetrelimab, a PD-1 Inhibitor
Oral presentation at ESMO Annual Congress 2021 – featured in a late-breaking abstract – reports efficacy and safety of BALVERSA® in combination with a PD-1 inhibitor in bladder cancer