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Press release / Jul 24, 2020

Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease

If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe CHMP opinion supported by data showing Adakveo significantly reduced the rate of vaso-…
Press release / Apr 13, 2015

Gilenya® data at AAN to highlight Novartis leadership in innovation with new MS assessment methods to benefit patients and physicians

New analysis will confirm high efficacy of Gilenya® in achieving 'no evidence of disease activity' (NEDA4) in previously-treated highly-active RMS patients Separate analyses will show adding…
Press release / Jul 07, 2015

Novartis' new heart failure medicine LCZ696, now called Entresto(TM), approved by FDA to reduce risk of cardiovascular death and heart failure hospitalization

First in the world approval brings hope of longer life and fewer hospitalizations for millions of Americans with heart failure with reduced ejection fraction Entresto is the first and only treatment…
Press release / Jul 21, 2017

Novartis receives positive CHMP opinion for Rydapt® (midostaurin) for newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM)

Recommendation based on largest trial in FLT3-mutated AML to date, showing 23% reduction in the risk of death with Rydapt treatment regimen[1] If approved, Rydapt would represent the first…
Ad hoc release / Nov 24, 2025

Novartis receives FDA approval for Itvisma®, the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA)

Ad hoc announcement pursuant to Art. 53 LR Itvisma (onasemnogene abeparvovec-brve) demonstrated improved motor function and stabilization in patients regardless of SMA treatment history in Phase III…
Press release / Sep 06, 2019

Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA Breakthrough Therapy Designation for patients with MET-mutated advanced non-small cell lung cancer

Currently, there are no targeted therapies approved to treat MET exon14 skipping-mutated non-small cell lung cancer (NSCLC), a particularly aggressive form of the diseaseBreakthrough Therapy…
Press release / Apr 24, 2017

Novartis real-world data at AAN confirms benefit of Gilenya® on four key measures of disease activity in relapsing MS

Over 16 months, more than 75% of patients on Gilenya had either no relapses, no new or enlarged MRI lesions or no disability progression; around 58% showed brain shrinkage levels broadly within the…
Press release / Sep 04, 2015

Novartis receives EU approval for Farydak®, the first in its class of anticancer agents approved for patients with multiple myeloma

Farydak (panobinostat) combination is approved in the EU for patients with multiple myeloma who received >=2 prior regimens including bortezomib and IMiD[1] In clinical trials, Farydak…
Press release / Jun 02, 2018

New Novartis data presented at ASCO find nearly half of CML patients treated with Tasigna® remain in remission almost three years after stopping therapy

ENESTop and ENESTfreedom data evaluate Treatment-free Remission (TFR) rates at 144 weeks among eligible Ph+ CML-CP patients who stopped Tasigna® Findings further support durability and…
Press release / May 01, 2021

Novartis Phase III Beovu® data show potential for fluid resolution in more diabetic macular edema patients with fewer injections versus aflibercept

In KESTREL and KITE, Beovu (brolucizumab) 6 mg met the primary endpoints of non-inferiority in change in best corrected visual acuity from baseline versus aflibercept 2 mg at year one in diabetic…

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