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Agosto 10, 2023

United States

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

Luglio 28, 2023

United States

Janssen Submits Supplemental New Drug Application to U.S. FDA Seeking Expanded Pediatric Indication for HIV-1 Therapy EDURANT®

Luglio 21, 2023

Belgium

Janssen Receives Positive CHMP Opinions for Novel Bispecific Antibodies TALVEY®▼ (talquetamab) and TECVAYLI®▼ (teclistamab) for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma

Luglio 17, 2023

United States

Treatment with RYBREVANT® (amivantamab-vmjw) Plus Chemotherapy Resulted in Statistically Significant and Clinically Meaningful Improvement in Progression-Free Survival in Patients with Newly Diagnosed EGFR Exon 20 Insertion Mutation-Positive Non-Small Cel

Luglio 04, 2023

United States

Janssen Announces Positive Topline Results for JNJ-2113—a Novel, First and Only Oral IL-23 Receptor Antagonist Peptide in Development for Moderate-to-Severe Plaque Psoriasis

Giugno 26, 2023

United States

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)

Giugno 26, 2023

Belgium

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)

Giugno 06, 2023

United States

Janssen Submits Supplemental Biologics License Application to U.S. FDA Seeking Approval of CARVYKTI® for the Earlier Treatment of Patients with Relapsed or Refractory Multiple Myeloma

Giugno 05, 2023

United States

Janssen Presents Longer-Term Data for TECVAYLI® (teclistamab-cqyv) Showing a Duration of Response of 22 Months in Patients with Relapsed or Refractory Multiple Myeloma

Giugno 05, 2023

United States

CARVYKTI® (ciltacabtagene autoleucel) Reduces Risk of Disease Progression or Death by 74 Percent in Earlier-Line Multiple Myeloma Treatment in the Landmark Phase 3 CARTITUDE-4 Study

Giugno 05, 2023

United States

Janssen Announces BALVERSA® (erdafitinib) Improved Overall Survival Versus Chemotherapy in Patients with Metastatic or Unresectable Urothelial Carcinoma and Selected Fibroblast Growth Factor Receptor Gene Alterations After Prior Anti-PD-(L)1 Treatment

Giugno 04, 2023

United States

New Long-Term Data from the CHRYSALIS Study Show Median PFS Not Reached after 33.6 Months of Follow Up with First-Line Use of RYBREVANT® (amivantamab-vmjw) and Lazertinib Combination Therapy in Patients with Treatment-Naïve EGFR-Mutated Advanced NSCLC