Newsroom

March 5, 2026

Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line

Approval based on unprecedented Phase 3 data demonstrating statistically significant improvements in progression‑free survival and overall survival versus standard of care regimens 83.3% of patients were alive at three years, indicating durable clinical benefit

Innovative Medicine

March 3, 2026

Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)

Fast Track designation reflects the unmet need in this serious disease and enables the potential for an accelerated FDA review timeline The designation is supported by a Phase 2 study in which nipocalimab demonstrated reduction in lupus disease activity and potential for steroid sparing Systemic lupus erythematosus is a debilitating, chronic autoantibody-driven disease affecting multiple organs, with limited treatment options and risk of irreversible organ damage Johnson & Johnson is actively enrolling patients in a Phase 3 study of adults with active systemic lupus erythematosus

Innovative Medicine

February 26, 2026

Early study results from Johnson & Johnson show promising antitumor activity with combination of pasritamig and docetaxel in advanced prostate cancer

Combination demonstrates deep PSA responses and favorable safety profile with plans to advance into Phase 3 Data highlight the potential of this first-in-class next-generation T-cell engager to expand the role of immunotherapy in prostate cancer

Innovative Medicine

February 24, 2026

Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)

Data from the pivotal ENERGY trial showed IMAAVY® produced a rapid and durable hemoglobin responsea in wAIHA Currently no FDA-approved therapies are available for wAIHA, a rare, heterogeneous, life-threatening disease in which pathogenic immunoglobulin (IgG) autoantibodies attach to and destroy red blood cells, leading to debilitating anemia

Innovative Medicine

February 23, 2026

Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer

Subcutaneous (SC) amivantamab reduces administration from hours to minutes, with efficacy and safety consistent with intravenous (IV) amivantamab1,2,3,4,5 SC amivantamab is now authorised across all previously approved IV indications, offering fewer administration-related reactions and new dosing options1,2,3,4,5,6

Innovative Medicine

February 21, 2026

TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years

More than 80% of those treated with TREMFYA® were in clinical remission and more than 50% were in endoscopic remission at Week 140 of the QUASAR long-term extension study, showing lasting disease control for patients 78% of patients achieved intestinal healing at both the tissue and visual level (histo-endoscopic mucosal improvement)

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Press releases

Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line

Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)

Early study results from Johnson & Johnson show promising antitumor activity with combination of pasritamig and docetaxel in advanced prostate cancer

Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)

Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer

TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years

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Newsroom

Press releases

Johnson & Johnson Announces U.S. FDA Approval of TECVAYLI® plus DARZALEX FASPRO® for Relapsed/Refractory Multiple Myeloma, Offering a Potential New Standard of Care as Early as Second Line

Johnson & Johnson therapy nipocalimab granted U.S. FDA Fast Track designation in systemic lupus erythematosus (SLE)

Early study results from Johnson & Johnson show promising antitumor activity with combination of pasritamig and docetaxel in advanced prostate cancer

Johnson & Johnson seeks FDA approval of IMAAVY® (nipocalimab-aahu) as the first-ever FDA-approved treatment for warm autoimmune hemolytic anemia (wAIHA)

Subcutaneous RYBREVANT®▼ (amivantamab) approved by European Commission for every-three-week and every-four-week dosing for patients with advanced EGFR-mutated non-small cell lung cancer

TREMFYA® (guselkumab) long-term data show sustained clinical and endoscopic remission in ulcerative colitis through 3 years

You are now leaving jnj.com/innovativemedicine