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Press release / Aug 25, 2023

Sandoz receives FDA approval for Tyruko® (natalizumab-sztn), first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis

Biosimilar Tyruko® approved for all indications of reference medicine, with same dosing and administration schedule Sandoz continues to expand access to much-needed medications for patients…
Press release / Nov 04, 2021

New data at ASH spotlight Novartis recently approved Scemblix®, next-generation CAR-T platform and expanding hematology portfolio

New longer-term efficacy and safety data from pivotal Phase III ASCEMBL study for recently US-approved Scemblix® (asciminib) in patients with PH+ CML-CPEarly findings from YTB323 and PHE885 CAR-T…
Press release / Jan 19, 2015

Novartis Cosentyx(TM) is the first IL-17 inhibitor to receive EU approval for first-line treatment of moderate-to-severe psoriasis patients

Cosentyx is the only biologic that can be used as first-line systemic therapy in the treatment of psoriasis and as an alternative to treatments that have significant side effects[1]; all other…
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 / May 30, 2018

FDA expedites review of Novartis drug Promacta® for first-line severe aplastic anemia (SAA)

Promacta receives FDA Priority Review for first-line treatment of SAA based on data showing 52% complete response rate and 85% overall response rate when added to standard immunosuppressive therapy (…
Press release / Apr 15, 2024

New Novartis Fabhalta® (iptacopan) data show clinically meaningful and statistically significant proteinuria reduction of 38.3% versus placebo for patients with IgA nephropathy (IgAN)

APPLAUSE-IgAN is first and only Phase III study to demonstrate significant proteinuria reduction by targeting the complement system in patients with IgAN1IgAN is a heterogeneous, progressive, rare…
Ad hoc release / Aug 08, 2024

Novartis receives FDA accelerated approval for Fabhalta® (iptacopan), the first and only complement inhibitor for the reduction of proteinuria in primary IgA nephropathy (IgAN)

Ad hoc announcement pursuant to Art. 53 LR Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm,…
Press release / Apr 19, 2017

NIH study in NEJM shows Novartis drug eltrombopag as first-line therapy with standard treatment improves responses in severe aplastic anemia

NIH study found 58% of patients with treatment-naïve severe aplastic anemia (SAA) achieved a complete response when eltrombopag was given at the initiation of and concurrently with standard…
Press release / Nov 16, 2018

FDA approves Novartis drug Promacta® for first-line SAA and grants Breakthrough Therapy designation for additional new indication

Promacta receives FDA approval for first-line treatment of severe aplastic anemia (SAA) and Breakthrough Therapy designation for low platelet counts in people exposed to radiation Approval…