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Johnson & Johnson's nipocalimab granted U.S. FDA Breakthrough Therapy Designation for the treatment of individuals at high risk for severe hemolytic disease of the fetus and newborn (HDFN)

/PRNewswire/ -- Johnson & Johnson today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for...

Landmark Phase 3 MARIPOSA Study Shows

Early data show an overall survival trend favoring the combination of amivantamab and lazertinib compared to osimertinib; consistent results seen in...

First Results with Erdafitinib-Releasing Intravesical

Investigational TAR-210 first-in-human results highlight the potential for local sustained release of erdafitinib with a novel intravesical delivery...

Results from Phase 2 THOR-2 Study Showed Improved Rates of

Data from Cohort 1 of the Phase 2 THOR-2 study showed oral erdafitinib reduced the risk of disease recurrence or death compared with intravesical...

New Safety Data Suggests SPRAVATO®▼ (Esketamine Nasal

Beerse, Belgium, Oct. 08, 2023 (GLOBE NEWSWIRE) -- The new safety data is from the ESCAPE-TRD Phase 3b study1Additional findings from this study showed...

Janssen Submits Marketing Authorisation Application to the

Pending approval, erdafitinib, an investigational, once-daily oral pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor,1 will become the...

Janssen Submits Marketing Authorisation Application to the European Medicines Agency Seeking Approval of Erdafitinib for the Treatment of Patients with Locally Advanced or Metastatic Urothelial Cancer with Susceptible FGFR Alterations

U.S. FDA Approves TALVEY™ (talquetamab-tgvs), a First-in-Class Bispecific Therapy for the Treatment of Patients with Heavily Pretreated Multiple Myeloma

/PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) has granted...

Janssen Receives Positive CHMP Opinions for Novel

Talquetamab is the first therapy targeting GPRC5D to receive a positive CHMP Opinion Teclistamab, the first BCMA-targeting bispecific antibody to...

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)

/PRNewswire/ -- The Janssen Pharmaceutical Companies of Johnson & Johnson today announced positive results from the proof-of-concept Phase 2 open-label UNITY...