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Press release / Sep 10, 2022

Novartis Cosentyx® shows clinically meaningful symptom improvements in patients with hidradenitis suppurativa in pivotal Phase III trials

Results from two parallel trials show Cosentyx® (secukinumab) demonstrated superior efficacy vs placebo with statistically significant improvement in hidradenitis suppurativa (HS) signs and…
Ad hoc release / Jan 26, 2018

Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Lutathera marks first FDA Approval for a Peptide Receptor Radionuclide Therapy (PRRT) Advanced Accelerator Applications is a newly established subsidiary of Novartis Lutathera…
Press release / Mar 04, 2024

Novartis presents new data on safety and efficacy of Zolgensma, including maintained and improved motor milestones in older and heavier children with SMA

The SMART study supplements a growing body of evidence on the use of Zolgensma in a patient population older and heavier (1.5 – 9.1 years of age) than the children treated in previous 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 / Dec 09, 2020

Novartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancer

MONALEESA-7 median overall survival (OS) results reinforce Kisqali as the CDK4/6 inhibitor with unrivaled OS evidence1Kisqali plus endocrine therapy had a median OS of nearly five years (58.7…
Press release / May 19, 2021

Novartis to unveil new data at ASCO and EHA from its robust portfolio, including overall survival in prostate and breast cancer

Overall survival and radiographic PFS from phase III study of investigational radioligand therapy 177Lu-PSMA-617 VISION trial of patients with metastatic castration-resistant prostate cancer to be…
Press release / Oct 27, 2024

Novartis oral Fabhalta® (iptacopan) sustained clinically meaningful results at one year in Phase III C3 glomerulopathy (C3G) trial

New APPEAR-C3G data show Fabhalta sustained proteinuria reduction at 12 months1Upon Fabhalta initiation, improvement observed in estimated glomerular filtration rate (eGFR) slope – a key measure of…
Press release / Nov 16, 2018

Novartis receives positive CHMP opinion to expand Kisqali® combination therapy to all women with HR+/HER2- locally advanced or metastatic breast cancer

Kisqali is the CDK4/6 inhibitor with the largest body of first-line evidence demonstrating consistent, superior and sustained efficacy vs. endocrine therapy alone[1] CHMP opinion is…
Press release / Dec 03, 2018

Novartis announces FDA filing acceptance and Priority Review of AVXS-101, a one-time treatment designed to address the genetic root cause of SMA Type 1

The AVXS-101, now known as ZOLGENSMA® (onasemnogene abeparvovec-xxxx)[1], filing is supported by data from the START trial which demonstrated a dramatic increase in survival and transformative…
Press release / Aug 05, 2020

Novartis announces NEJM publication of Phase III ASCLEPIOS trials demonstrating superior efficacy of ofatumumab in patients with relapsing multiple sclerosis

Ofatumumab is a targeted B-cell therapy that delivers superior efficacy with a similar safety profile when compared with teriflunomide, a commonly prescribed oral treatment for multiple sclerosis1…