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Innovative Medicine
U.S. FDA Approves CARVYKTI™ (ciltacabtagene autoleucel), Janssen’s First Cell Therapy, a BCMA-Directed CAR-T Immunotherapy for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma
In the pivotal clinical study, 98 percent of patients with relapsed or refractory multiple myeloma responded to a one-time treatment with ciltacabtagene autoleucel and 78 percent of patients who responded experienced a stringent complete response
Janssen Presents New Data Demonstrating the Combination of Niraparib and Abiraterone Acetate Plus Prednisone Significantly Improved Radiographic Progression-Free Survival as a First-Line Therapy in Patients with HRR Gene-Mutated Metastatic Castration-Resistant Prostate Cancer
Initial results from Phase 3 MAGNITUDE study, to be featured in a late-breaking oral presentation at ASCO GU, highlight subset of patients with mCRPC most likely to benefit from treatment
U.S. FDA Approves CABENUVA (rilpivirine and cabotegravir) for Use Every Two Months, Expanding the Label of the First and Only Long-Acting HIV Treatment
CABENUVA offers virologically suppressed adults living with HIV an injectable treatment option administered as few as six times a year.
Janssen Data at ASCO GU Demonstrate Longstanding Leadership in Prostate Cancer and Commitment to Advancing Potential New Therapeutic Options for Genitourinary Cancers
Initial results from Phase 3 MAGNITUDE study of niraparib in combination with abiraterone acetate plus prednisone as a first-line therapy in patients with metastatic castration-resistant prostate cancer featured as an oral presentation New data for ERLEADA® (apalutamide) build on more than a decade of experience in prostate cancer; updated clinical trial information for novel drug delivery system TAR-200 plus cetrelimab in early-stage bladder cancer to be presented
A Newly Published Network Meta-Analysis (NMA) Found TREMFYA® (guselkumab) Ranked Highest for Overall Level of Skin Clearance and Provided Positive Joint Efficacy Among Active Psoriatic Arthritis (PsA) Therapies
The NMA indirectly compared all published Phase 3 data for approved treatments for adults with active PsA TREMFYA ranked highest among 23 active PsA treatment regimens on skin clearance (PASI 90 response) and showed positive joint efficacy (ACR20), including inhibition of structural damage (vdH-S)
Johnson & Johnson COVID-19 Vaccine Demonstrates 85 Percent Effectiveness against Hospitalization in South Africa when Omicron was Dominant
Separate analysis showed Johnson & Johnson COVID-19 vaccine booster generated 41-fold increase in neutralizing antibodies and a 5-fold increase in T-cells against Omicron
FDA Approves Two New Indications for XARELTO® (rivaroxaban) to Help Prevent and Treat Blood Clots in Pediatric Patients
XARELTO® is available as both an oral tablet and oral suspension formulation for use in appropriate children less than 18 years of age Convenient oral suspension formulation advances standard of care for children; alleviates administration challenges found with injectable alternatives XARELTO® now has 11 indications, the most of any direct oral anticoagulant (DOAC), and is the only Factor Xa anticoagulant to offer flexible weight-based dosing for pediatric patients
Johnson & Johnson Announces Positive CHMP Opinion for a Booster Shot of its COVID-19 Vaccine
CHMP recommendation based on data showing a booster (second shot) of the Johnson & Johnson COVID-19 vaccine increased protection to 75 percent against symptomatic COVID-19 infection globally Data also demonstrated 100 percent protection against severe COVID-19, at least 14 days post-booster vaccination The Johnson & Johnson COVID-19 vaccine, when given as a booster or primary shot, was generally well-tolerated