Janssen — Drug & Asset Intelligence | Humanexa Signals

RegulatoryAugust 11, 2026

Long-term safety study initiated for ciltacabtagene autoleucel (cilta-cel)

A long-term safety study has been initiated to collect follow-up data on delayed adverse events associated with ciltacabtagene autoleucel (cilta-cel), CAR-T therapy developed by Janssen for the treatment of multiple myeloma.

Sponsor company

Mechanism of action

Recent signals(35)

FDA Accepts Supplement for INVOKAMET XR by Janssen

FDA Accepts Supplemental Application for INVOKAMET XR by Janssen

FDA accepts supplemental NDA for Invokana (canagliflozin) by Janssen

FDA Accepts Supplement Application for DARZALEX by Janssen Biotech

FDA Accepts Supplement for Tremfya (Guselkumab) by Janssen Biotech

Long-term safety study initiated for ciltacabtagene autoleucel (cilta-cel)

FDA Accepts Supplement Application for TECVAYLI (BLA761291)

FDA Accepts Supplemental BLA for TALVEY (TALQUETAMAB-TGVS) by Janssen

FDA Accepts Supplement for Lazertinib Mesylate by Janssen Biotech

FDA Accepts Supplement Application for STELARA by Janssen Biotech

FDA Accepts Supplemental Application for SPRAVATO (Esketamine)

FDA Accepts Supplemental NDA for Concerta by Janssen Pharmaceuticals

FDA Accepts Supplement for INVOKANA (Canagliflozin) by Janssen

FDA Accepts Supplement Application for DARZALEX (Daratumumab)

FDA Accepts Supplement for TREMFYA (Guselkumab) by Janssen Biotech

Janssen Launches Global Registry for Inherited Retinal Diseases

Janssen's Apalutamide Study Targets mCRPC in Chinese Patients

Janssen's Apalutamide Study Targets High-Risk Prostate Cancer Pre-Radical Prostatectomy

Long-term safety and efficacy study of ibrutinib initiated by Janssen

FDA Accepts Supplement Application for TECVAYLI by Janssen Biotech

Study on Plasma Exchange vs. Daratumumab for Light Chain Cast Nephropathy

FDA Accepts Supplement for SPORANOX (Itraconazole) by Janssen

FDA Accepts Supplement Application for LAZCLUZE (Lazertinib Mesylate)

FDA Accepts Supplement Application for ERLEADA (Apalutamide)

Teclistamab Combination Study in Multiple Myeloma Initiated by Janssen

Janssen initiates rollover study for long-term safety in multiple cancers

Janssen's Guselkumab Compared to Risankizumab in Crohn's Disease Study Initiated

Janssen's Amivantamab Study in Advanced NSCLC Evaluates Safety and Efficacy

Phase 1b/2 Study of JNJ-90014496 for B-Cell Non-Hodgkin Lymphoma Initiated by Janssen

JNJ-87562761 Phase 2 Study Initiated for Relapsed/Refractory Multiple Myeloma

Janssen's Amivantamab and Docetaxel Combo in NSCLC Enters Phase 1/2 Trials

FDA Accepts Supplement Application for STELARA by Janssen Biotech

FDA Accepts Application for Canagliflozin by Apotex

FDA Accepts Supplement for SPRAVATO (Esketamine) by Janssen

Janssen's Guselkumab Trial Targets Skin of Color Patients with Psoriasis

Upcoming milestones

Related catalysts

Indications

Therapeutic areas

Get signals before the market moves