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Press release / May 26, 2017

Novartis receives FDA approval for expanded use of Zykadia® in first-line ALK-positive metastatic non-small cell lung cancer (NSCLC)

In ALK-positive metastatic NSCLC patients, Zykadia median progression-free survival (PFS) was 16.6 months, compared to 8.1 months with chemotherapy[1] The overall intracranial response rate…
Press release / May 27, 2020

Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease

New MONALEESA-7 (M7) and MONALEESA-3 (M3) subgroup analysis to be presented during ASCO20 Virtual Scientific Program Subgroup analysis shows Kisqali plus endocrine therapy extended life…
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…
Press release / Apr 30, 2019

New data at AAN reinforce Novartis commitment to transforming the lives of people of all ages who live with neurological conditions

Novartis leads the way at AAN with 52 abstracts, showcasing its broad portfolio of transformative medicines and innovative solutions for people living with spinal muscular atrophy (SMA), multiple…
Press release / Apr 21, 2015

Data at AAN showed Gilenya® high efficacy in achieving 'no evidence of disease activity' in previously-treated highly-active MS patients

New FREEDOMS/FREEDOMS II sub-group analysis showed Gilenya-treated patients were six-times more likely to achieve 'no evidence of disease activity (NEDA4)' vs placebo NEDA4 is based on four…
Ad hoc release / Nov 15, 2019

New Novartis medicine Adakveo® (crizanlizumab) approved by FDA to reduce frequency of pain crises in individuals living with sickle cell disease

Sickle cell pain crises are unpredictable, severe events associated with life-threatening complications1 Adakveo reduced the annual rate of sickle cell pain crises by 45% compared to placebo (1.…
Press release / Jan 10, 2022

Novartis and Molecular Partners report positive topline data from Phase 2 study for ensovibep (MP0420), a DARPin antiviral therapeutic for COVID-19

Topline results from the randomized EMPATHY Part A study in acute COVID-19 ambulatory patients comparing single intravenous doses of ensovibep, a DARPin antiviral therapeutic candidate vs. placebo,…
Ad hoc release / Mar 23, 2022

Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer

Ad hoc announcement pursuant to Art. 53 LR FDA also approved complementary diagnostic imaging agent, Locametz®, after radiolabeling with gallium-68 for the identification of PSMA-positive…
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 / Apr 20, 2023

Novartis presents new five-year data on disability outcomes and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis

The ALITHIOS open-label extension study showed continuous treatment with Kesimpta® (ofatumumab) for up to five years in relapsing multiple sclerosis (RMS) patients was associated with reduced risk of…

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