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Janssen Submits Marketing Authorisation Application to the European Medicines Agency (EMA) Seeking Approval of Single Tablet Combination Therapy (STCT) of Macitentan and Tadalafil for Treatment of Patients with Pulmonary Arterial Hypertension (PAH)
Jun 26, 2023 Belgium This is the first and only single tablet combination therapy to be submitted for review in Europe for this rare, progressive disease If approved, Janssen’s comprehensive PAH portfolio has the potential to cover all guideline ...
Update on Janssen’s BACE Inhibitor Program Regarding the Dominantly Inherited Alzheimer’s Network Trial (DIAN-TU)
Article Type: Neuroscience Update on Janssen’s BACE Inhibitor Program Regarding the Dominantly Inherited Alzheimer’s Network Trial (DIAN-TU) The statement below is an update to our May 17, 2018, announcement found here. Titusville, New Jersey, May 25, ...
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
May 25, 2023 United States 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 ...
DARZALEX® (daratumumab)-based regimens significantly improve clinical outcomes in both transplant-eligible and-ineligible patients who are newly diagnosed with multiple myeloma
Jun 03, 2024 88 percent of transplant-eligible patients achieved a complete response or better, and 47 percent of patients sustained MRD-negativity for longer than one year with DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj)-based induction, ...
ESMO 2021
LATEST NEWS RYBREVANT® (amivantamab-vmjw) Provides Higher Activity and Longer Duration of Response When Used in Combination with Lazertinib in Patients with Advanced EGFR-Mutant Non-Small Cell Lung Cancer Who Have Failed Osimertinib New Data on ...
New Phase 2 Data Demonstrate Potential Benefit of Nipocalimab for Pregnant Individuals at High Risk of Early-Onset Severe Hemolytic Disease of the Fetus and Newborn (HDFN)
Jun 26, 2023 United States 92 percent of pregnancies treated with nipocalimab resulted in a live birth, with 54 percent delivering at or after 32 weeks without intrauterine transfusions 1 SPRING HOUSE, PENNSYLVANIA, JUNE 26, 2023 – The Janssen ...
Janssen Receives Positive CHMP Opinion for CARVYKTI®▼ (ciltacabtagene autoleucel; cilta-cel) for Treatment in Earlier Lines of Relapsed and Refractory Multiple Myeloma
Feb 23, 2024 Belgium Results from the Phase 3 CARTITUDE-4 study, which supported the CHMP recommendation, showed that cilta-cel has the potential to offer significant benefit to patients in earlier lines of treatment [1] Most patients with multiple ...
Rare Disease Day
This year marks the 11th International Rare Disease Day. Learn more here. Event Date: Wednesday, February 28, 2018- 06:30 Event End Date: Wednesday, February 28, 2018- 06:30 ...
Partners in Precision Medicine
Our Focus on Collaborations and Partnerships We believe that innovation can come from anywhere and is often the result of unified efforts from multiple collaborators. Janssen has a demonstrated appreciation for the value of collaboration and partnership, ...
Johnson & Johnson submits application to U.S. FDA seeking approval of TREMFYA® (guselkumab) for the treatment of moderately to severely active Crohn’s disease
Jun 21, 2024 Submission is supported by 48-week results from the Phase 3 GALAXI and GRAVITI programs TREMFYA® is the only IL-23 inhibitor to demonstrate strong endoscopic outcomes with subcutaneous (SC) induction, consistent with intravenous (IV) ...