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Press release / Jan 16, 2026

Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1Distinction expedites development and review of treatments for serious…
Press release / Apr 28, 2017

Novartis receives FDA approval for Rydapt® in newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of systemic mastocytosis (SM)

Approval in newly diagnosed FLT3-mutated AML represents the first new treatment in more than 25 years[1],[2] Rydapt treatment regimen in FLT3-mutated AML demonstrated a significant improvement…
Press release / Nov 23, 2022

Novartis and Medicines for Malaria Venture announce decision to move to Phase 3 study for novel ganaplacide/lumefantrine-SDF combination in adults and children with malaria

Novartis and Medicines for Malaria Venture (MMV) announce decision to move to Phase 3 study for novel non-artemisinin combination to treat uncomplicated malariaThis novel combination also contains an…
Press release / Nov 14, 2016

Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis

Priority Review based on data from the largest clinical trials conducted to date in each indication[1],[2] Designation will shorten FDA expected review time to within six months[3]; EMA also…
Press release / Jun 02, 2021

Novartis Kymriah® pivotal trial demonstrates strong response rates and a remarkable safety profile in relapsed or refractory follicular lymphoma

Primary analysis of ELARA trial demonstrated a 66% complete response rate and 86% overall response rate with one-time Kymriah infusion1Robust response observed in heavily pretreated patients in…
Press release / Jun 29, 2016

Novartis PKC412 (midostaurin) pivotal data published in NEJM show 60% response rate in advanced systemic mastocytosis (SM)

In the largest and longest-running prospective trial in advanced SM, 60% of patients achieved complete or partial resolution of organ damage[1] Advanced SM is rare and has a poor prognosis[…
Ad hoc release / Dec 22, 2021

FDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a year

Ad hoc announcement pursuant to Art. 53 LR With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol…
Press release / Nov 05, 2018

Novartis R&D update highlights industry leading development pipeline including potential blockbusters and advanced therapy platforms

26 potential blockbusters in confirmatory development[1]. 13 projects in clinical development across Cell, Gene & Radioligand therapies. 60 major submissions[2] planned from 2019 to 2021…
Press release / Mar 24, 2020

AveXis presents AVXS-101 IT data demonstrating remarkable increases in HFMSE scores and a consistent clinically meaningful response in older patients with SMA Type 2

SMA Type 2 patients between two and five years of age who received Dose B met the primary efficacy endpoint with a remarkable mean increase of 6.0 points in HFMSE scores from baseline to month 12,…
Ad hoc release / Mar 23, 2021

Novartis announces positive result of phase III study with radioligand therapy 177Lu-PSMA-617 in patients with advanced prostate cancer

Phase III VISION study with 177Lu-PSMA-617 met both primary endpoints, significantly improving overall survival (OS) and radiographic progression-free survival (rPFS) in patients with PSMA-positive…

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