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Press release / Mar 25, 2022

Novartis receives positive CHMP opinion for Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe

Positive opinion paves way for third indication in Europe for Kymriah, a potentially definitive single infusion CAR-T cell therapy treatment optionCHMP opinion based on Phase II global ELARA trial…
Press release / Jun 22, 2022

Novartis receives European Commission approval for Tabrecta® for the treatment of METex14 skipping advanced non-small cell lung cancer

Tabrecta® (capmatinib) provides a new targeted therapy option for previously-treated patients in Europe who are living with advanced non-small cell lung cancer (NSCLC) harboring alterations leading…
Press release / May 05, 2022

Novartis receives European Commission approval for Jakavi® to be the first post-steroid treatment for acute and chronic graft-versus-host disease

Jakavi is the first JAK1/2 inhibitor available for patients in Europe who previously had no approved therapies for the treatment of steroid-refractory graft-versus-host disease (GvHD)1,2 In clinical…
Ad hoc release / Mar 19, 2020

Novartis receives approval from Japanese Ministry of Health, Labour and Welfare for Zolgensma® the only gene therapy for patients with spinal muscular atrophy (SMA)

Zolgensma® (onasemnogene abeparvovec), a one-time administered gene therapy, is approved for the treatment of SMA in patients under the age of two, including those who are pre-symptomatic at…
Press release / Mar 30, 2021

Novartis receives EU approval for Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis

There are more than 1 million people living with multiple sclerosis (MS) in Europe1, Kesimpta® (ofatumumab) addresses the current unmet need for a high-efficacy disease-modifying therapy (DMT) that…
Press release / Dec 16, 2020

Novartis investigational oral therapy iptacopan (LNP023) receives FDA Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3G

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, resulting in debilitating symptoms that can impact patients’ quality of life1–3C3 glomerulopathy (C3G) is a…
Press release / Nov 29, 2018

Novartis announces EU approval of Gilenya® for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe

Approval based on landmark PARADIGMS study showing Gilenya (fingolimod) significantly reduced relapse rates by 82% vs interferon beta-1a; additionally, 85.7% of Gilenya patients were relapse-free…
Press release / May 27, 2021

Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the treatment of COVID-19

EMPATHY global multi-center Phase 2 - 3 study, recruiting patients with COVID-19 infection, aiming to prevent worsening symptoms and hospitalizationThe study plans to enroll 2100 patients, with 400…
Press release / Aug 20, 2015

Novartis drug Odomzo® gains EU approval for locally advanced basal cell carcinoma, providing new non-invasive therapy for patients

Approval follows positive CHMP opinion based on pivotal Phase II study showing durable objective response rate per central review of 56% in patients with laBCC[1] Basal cell carcinoma is…
Press release / May 19, 2020

AveXis receives EC approval and activates “Day One” access program for Zolgensma®, the only gene therapy for spinal muscular atrophy (SMA)

Zolgensma® (onasemnogene abeparvovec) is conditionally approved in Europe for the treatment of patients with spinal muscular atrophy (SMA) and a clinical diagnosis of SMA Type 1; or SMA patients with…