Johnson & Johnson presenta sendas solicitudes en Estados Unidos y la Unión Europea para obtener la aprobación de DARZALEX FASPRO® y DARZALEX® (daratumumab) en monoterapia por vía subcutánea para el mieloma múltiple quiescente de alto riesgo
November 08, 2024 07:28 ET
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Janssen Cilag International NV
Si se aprobase, daratumumab se convertiría en la primera opción de tratamiento para pacientes con mieloma múltiple quiescente con alto riesgo de desarrollar la enfermedad, ofreciendo un nuevo enfoque...
Johnson & Johnson submits applications in the U.S. and EU seeking approval of DARZALEX FASPRO®/DARZALEX® (daratumumab) as subcutaneous monotherapy for high-risk smouldering multiple myeloma
November 08, 2024 07:00 ET
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Janssen Cilag International NV
If approved, daratumumab will become the first treatment option for patients with smouldering multiple myeloma at high-risk of developing multiple myeloma, offering a novel approach to treat before...
DARZALEX® (daratumumab)-SC based quadruplet regimen approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible
October 23, 2024 02:59 ET
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Janssen Cilag International NV
Phase 3 PERSEUS study of daratumumab subcutaneous (SC) formulation in combination with bortezomib, lenalidomide and dexamethasone induction and consolidation, followed by daratumumab SC and...
Nipocalimab muestra un control sostenido de la enfermedad en adolescentes que padecen miastenia gravis generalizada en un estudio fase 2/3
October 17, 2024 05:09 ET
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Janssen Cilag International NV
El ensayo mostró un control sostenido de la enfermedad durante 24 semanas en adolescentes de entre 12 y 17 años positivos a autoanticuerpos BEERSE, BÉLGICA , Oct. 17, 2024 (GLOBE NEWSWIRE) --...
Johnson & Johnson presenta domanda all’Agenzia europea per i medicinali per la terapia quadrupla basata su DARZALEX® (daratumumab) SC rivolta ai pazienti affetti da mieloma multiplo di nuova diagnosi
October 16, 2024 10:40 ET
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Janssen Cilag International NV
Richiesta supportata dai dati dello studio di Fase 3 CEPHEUS per il trattamento di pazienti con mieloma multiplo di nuova diagnosi per i quali non è previsto il trapianto come terapia iniziale.1 I...
Johnson & Johnson reicht bei der Europäischen Arzneimittel-Agentur einen Antrag für DARZALEX® (daratumumab)-Quadrupeltherapie in subkutaner Formulierung bei Patienten mit neu diagnostiziertem Multiplem Myelom ein
October 16, 2024 10:40 ET
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Janssen Cilag International NV
Der Antrag wird durch Daten aus der Phase III-Studie CEPHEUS zur Behandlung von Patienten mit neu diagnostiziertem Multiplem Myelom unterstützt, für die eine Transplantation als Ersttherapie nicht...
Johnson & Johnson dépose auprès de l’Agence européenne des médicaments une demande d’autorisation pour la quadrithérapie à base de DARZALEX® (daratumumab) par voie sous-cutanée dans le traitement des patients atteints d’un myélome multiple nouvellement diagnostiqué
October 16, 2024 10:40 ET
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Janssen Cilag International NV
La demande est étayée par les données de l’étude de la Phase 3 CEPHEUS pour le traitement des patients atteints d’un myélome multiple nouvellement diagnostiqué et pour lesquels une greffe n’est pas...
Nipocalimab demonstrates sustained disease control in adolescents living with generalised myasthenia gravis in the Phase 2/3 study
October 15, 2024 08:14 ET
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Janssen Cilag International NV
First FcRn blocker to demonstrate sustained disease control over 24 weeks in antibody positive adolescents aged 12 – 17 years, broadening the population in which nipocalimab has been studied ...
Johnson & Johnson submits application to the European Medicines Agency for DARZALEX® (daratumumab) SC-based quadruplet regimen for newly diagnosed multiple myeloma patients
October 10, 2024 04:42 ET
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Janssen Cilag International NV
Submission supported by data from the Phase 3 CEPHEUS study for the treatment of patients with newly diagnosed multiple myeloma for whom transplant is not planned as initial therapy1 Data showed...
La nuova combinazione di TALVEY®▼ (talquetamab) e TECVAYLI®▼ (teclistamab) comporta alti tassi di risposta e risposte durature in pazienti refrattari alla tripla classe con mieloma multiplo recidivato o refrattario, compresi i pazienti con malattia extramidollare
October 04, 2024 16:28 ET
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Janssen Cilag International NV
I dati dello studio sperimentale di Fase 1b RedirecTT-1 dimostrano un profilo di sicurezza coerente con le monoterapie talquetamab e teclistamab1 BEERSE, BELGIO, Oct. 04, 2024 (GLOBE NEWSWIRE) --...