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Innovative Medicine

Milvexian Granted U.S. FDA Fast Track Designation for All Three Indications Under Evaluation in Phase 3 Librexia Program: Ischemic Stroke, Acute Coronary Syndrome and Atrial Fibrillation

The Librexia program evaluating milvexian is unrivaled as the most comprehensive factor XIa inhibitor clinical development program to date and will provide extensive data from nearly 50,000 patients, with all three studies underway

First Phase 3 TREMFYA® (guselkumab) Data in Inflammatory Bowel Disease Show Positive Induction Results Among Patients with Moderately to Severely Active Ulcerative Colitis

Late-breaking data from the Phase 3 QUASAR Induction Study show statistically significant and clinically meaningful improvements among ulcerative colitis patients, including bio-naïve patients and those who have experienced treatment failure with advanced therapies

Janssen Enters Worldwide Collaboration and License Agreement with Cellular Biomedicine Group to Develop Next Generation CAR-T Therapies

Investigational CD20-targeted CAR-Ts Enhance Janssen’s B-cell Malignancy Portfolio Agreement Deepens Janssen’s Leadership in Oncology and Hematology, and Accelerates Commitment to Delivering Transformational Cell Therapies

Janssen Marks First Approval Worldwide for AKEEGA® (Niraparib and Abiraterone Acetate Dual Action Tablet) with EC Authorization for the Treatment of Patients with Metastatic Castration Resistant Prostate Cancer with BRCA1/2 Mutations

Approval for AKEEGA® is based on results from the Phase 3 MAGNITUDE study, a prospectively designed precision medicine study that includes the largest cohort to date of BRCA1/2-positive patients with untreated metastatic castration-resistant prostate cancer (mCRPC).1,2 Niraparib in combination with abiraterone acetate (AA), plus prednisone or prednisolone, significantly improved radiographic progression-free survival (rPFS) compared to standard of care in untreated mCRPC patients with BRCA1/2 mutations.3

Janssen to Highlight Innovation in Retinal Pipeline at the Association for Research in Vision and Ophthalmology (ARVO) 2023 Annual Meeting

Important new data on Janssen’s investigational gene therapy portfolio, including botaretigene sparoparvovec (bota-vec) and JNJ-1887, will be presented

ERLEADA® (apalutamide), First-and-Only Next-Generation Androgen Receptor Inhibitor with Once-Daily, Single-Tablet Option, Now Available in the U.S.

Addition of 240mg strength allows prescribers flexibility to prescribe one 240mg tablet or four 60mg tablets once-daily based on patient needs