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Johnson & Johnson (JNJ) FDA Events

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FDA Events for Johnson & Johnson (JNJ)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Johnson & Johnson (JNJ). Over the past two years, Johnson & Johnson has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AKEEGA, apalutamide, CAPLYTA, DARZALEX, Guselkumab, IMAAVY, and JNJ-2113. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Johnson & Johnson's Drugs in FDA Review

AKEEGA - FDA Regulatory Timeline and Events

AKEEGA is a drug developed by Johnson & Johnson for the following indication: In Disease Progression For BRCA-Altered Prostate Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

apalutamide - FDA Regulatory Timeline and Events

apalutamide is a drug developed by Johnson & Johnson for the following indication: For the treatment of prostate cancer (nmCRPC). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

CAPLYTA (Lumateperone) - FDA Regulatory Timeline and Events

CAPLYTA (Lumateperone) is a drug developed by Johnson & Johnson for the following indication: Depressive Episodes associated with Bipolar. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone - FDA Regulatory Timeline and Events

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone is a drug developed by Johnson & Johnson for the following indication: Multiple Myeloma After First / Subsequent Relapse. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Guselkumab - FDA Regulatory Timeline and Events

Guselkumab is a drug developed by Johnson & Johnson for the following indication: For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

IMAAVY - FDA Regulatory Timeline and Events

IMAAVY is a drug developed by Johnson & Johnson for the following indication: For the treatment of generalized myasthenia gravis (gMG). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

JNJ-2113 - FDA Regulatory Timeline and Events

JNJ-2113 is a drug developed by Johnson & Johnson for the following indication: Severely Active Ulcerative Colitis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

JNJ-4496 - FDA Regulatory Timeline and Events

JNJ-4496 is a drug developed by Johnson & Johnson for the following indication: In patients with relapsed or refractory large B-cell lymphoma (R/R LBCL). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

LAZCLUZE - FDA Regulatory Timeline and Events

LAZCLUZE is a drug developed by Johnson & Johnson for the following indication: For treatment of patients with EGFR-mutated advanced non-small cell lung cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Nipocalimab - FDA Regulatory Timeline and Events

Nipocalimab is a drug developed by Johnson & Johnson for the following indication: Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

PONVORY (ponesimod) - FDA Regulatory Timeline and Events

PONVORY (ponesimod) is a drug developed by Johnson & Johnson for the following indication: relapsing forms of multiple sclerosis (MS). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

RYBREVANT (amivantamab-vmjw) - FDA Regulatory Timeline and Events

RYBREVANT (amivantamab-vmjw) is a drug developed by Johnson & Johnson for the following indication: Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations. This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

RYBREVANT® (amivantamab-vmjw) - FDA Regulatory Timeline and Events

RYBREVANT® (amivantamab-vmjw) is a drug developed by Johnson & Johnson for the following indication: For patients with EGFR-mutated advanced lung cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

RYBREVANT®(amivantamab) - FDA Regulatory Timeline and Events

RYBREVANT®(amivantamab) is a drug developed by Johnson & Johnson for the following indication: For Advanced EGFR-Mutated Non-Small Cell Lung Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

SPRAVATO - FDA Regulatory Timeline and Events

SPRAVATO is a drug developed by Johnson & Johnson for the following indication: For adults with treatment-resistant depression. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

STELARA - FDA Regulatory Timeline and Events

STELARA is a drug developed by Johnson & Johnson for the following indication: For the treatment of pediatric Crohn’s disease. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TALVEY - FDA Regulatory Timeline and Events

TALVEY is a drug developed by Johnson & Johnson for the following indication: In patients with relapsed or refractory multiple myeloma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TAR-200 - FDA Regulatory Timeline and Events

TAR-200 is a drug developed by Johnson & Johnson for the following indication: In patients with intermediate risk non–muscle-invasive bladder cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TAR-210 - FDA Regulatory Timeline and Events

TAR-210 is a drug developed by Johnson & Johnson for the following indication: In Patients With High-Risk And Intermediate-Risk Non-Muscle-Invasive Bladder Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

TECVAYLI - FDA Regulatory Timeline and Events

TECVAYLI is a drug developed by Johnson & Johnson for the following indication: For patients with newly diagnosed multiple myeloma. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

VELYS™ Robotic-Assisted Solution - FDA Regulatory Timeline and Events

VELYS™ Robotic-Assisted Solution is a drug developed by Johnson & Johnson for the following indication: in Unicompartmental Knee Arthroplasty (UKA). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Johnson & Johnson FDA Events - Frequently Asked Questions

Yes, Johnson & Johnson (JNJ) has received FDA approval for RYBREVANT (amivantamab-vmjw). This page tracks recent and historical FDA regulatory events related to Johnson & Johnson's drug portfolio.

In the past two years, Johnson & Johnson (JNJ) has reported FDA regulatory activity for the following drugs: Guselkumab, RYBREVANT (amivantamab-vmjw), Nipocalimab, DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone, TAR-200, LAZCLUZE, TALVEY, JNJ-2113, IMAAVY, RYBREVANT®(amivantamab), SPRAVATO, RYBREVANT® (amivantamab-vmjw), apalutamide, CAPLYTA (Lumateperone), STELARA, JNJ-4496, AKEEGA, TECVAYLI, VELYS™ Robotic-Assisted Solution, PONVORY (ponesimod) and TAR-210.

The most recent FDA-related event for Johnson & Johnson occurred on July 8, 2025, involving CAPLYTA (Lumateperone). The update was categorized as "sNDA Filing," with the company reporting: "Johnson & Johnson announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) based upon long-term data evaluating the safety and efficacy of CAPLYTA® (lumateperone) for the prevention of relapse in schizophrenia."

Current therapies from Johnson & Johnson in review with the FDA target conditions such as:

  • For Treatment Of Adults With Moderately To Severely Active Ulcerative Colitis - Guselkumab
  • Advanced Non-Small Cell Lung Cancer with EGFR Exon 20 Insertion Mutations - RYBREVANT (amivantamab-vmjw)
  • Treatment of alloimmunisedc pregnant individuals at high risk of severe HDFN - Nipocalimab
  • Multiple Myeloma After First / Subsequent Relapse - DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) + Pomalidomide + Dexamethasone
  • In patients with intermediate risk non–muscle-invasive bladder cancer - TAR-200
  • For treatment of patients with EGFR-mutated advanced non-small cell lung cancer - LAZCLUZE
  • In patients with relapsed or refractory multiple myeloma - TALVEY
  • Severely Active Ulcerative Colitis - JNJ-2113
  • For the treatment of generalized myasthenia gravis (gMG). - IMAAVY
  • For Advanced EGFR-Mutated Non-Small Cell Lung Cancer - RYBREVANT®(amivantamab)
  • For adults with treatment-resistant depression - SPRAVATO
  • For patients with EGFR-mutated advanced lung cancer - RYBREVANT® (amivantamab-vmjw)
  • For the treatment of prostate cancer (nmCRPC) - apalutamide
  • Depressive Episodes associated with Bipolar - CAPLYTA (Lumateperone)
  • For the treatment of pediatric Crohn’s disease - STELARA
  • In patients with relapsed or refractory large B-cell lymphoma (R/R LBCL) - JNJ-4496
  • In Disease Progression For BRCA-Altered Prostate Cancer - AKEEGA
  • For patients with newly diagnosed multiple myeloma - TECVAYLI
  • in Unicompartmental Knee Arthroplasty (UKA). - VELYS™ Robotic-Assisted Solution
  • relapsing forms of multiple sclerosis (MS) - PONVORY (ponesimod)
  • In Patients With High-Risk And Intermediate-Risk Non-Muscle-Invasive Bladder Cancer, - TAR-210

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NYSE:JNJ) was last updated on 7/9/2025 by MarketBeat.com Staff
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