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Media Release / Sep 17, 2024

FDA approves Novartis Kisqali® to reduce risk of recurrence in people with HR+/HER2- early breast cancer

Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4/6 inhibitor adjuvant therapy1,2 …
Media Release / Sep 16, 2024

Novartis Kisqali® shows deepening benefit in new analysis, reducing the risk of recurrence by 28.5% in a broad population of patients with early breast cancer

Invasive disease-free survival benefit continued to increase after completion of the three-year treatment period across all patient subgroups, including those with node-negative disease1 …
Media Release / Sep 04, 2024

Novartis begins construction of two new radioligand therapy facilities in the US, expanding its world-class RLT manufacturing and supply network

Indianapolis site expansion will establish in-house production of isotopes critical for production of radioligand therapies (RLTs) for cancer treatment New facility in California will be…
Media Release / Aug 07, 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)

Fabhalta achieved a 44% proteinuria reduction from baseline in Phase III APPLAUSE-IgAN interim analysis, compared with 9% in placebo arm, demonstrating a clinically meaningful reduction of 38% vs.…
Media Release / Jul 29, 2024

Novartis Scemblix® granted FDA Priority Review for the treatment of adults with newly diagnosed CML

Priority Review based on ASC4FIRST Phase III study with Scemblix® data first to show significantly improved molecular response and a favorable safety and tolerability profile compared to standard…
Media Release / Mar 28, 2025

FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer

New indication approximately triples eligible patient population, allowing Pluvicto® to be used after one androgen receptor pathway inhibitor (ARPI) and now before chemotherapy Pluvicto…
Media Release / Mar 25, 2025

Novartis to present new data at AAN, including seven-year disability outcomes and safety analysis of Kesimpta® in people with relapsing multiple sclerosis

Long-term disability and safety data from ALITHIOS open-label extension study on continuous treatment with Kesimpta vs. later switch from teriflunomide in relapsing multiple sclerosis (RMS)…
Media Release / Mar 20, 2025

Novartis receives third FDA approval for oral Fabhalta® (iptacopan) - the first and only treatment approved in C3 glomerulopathy (C3G)

Phase III study showed sustained proteinuria reduction at one year with favorable safety1 Fabhalta is the only oral alternative complement pathway inhibitor thought to target the…
Media Release / Mar 13, 2025

Novartis named first-ever corporate pharmaceutical partner of the National Football League

The long-term, exclusive pharmaceutical category agreement is designed to turn fans' passion for the game into a commitment to better health Novartis sports partnership covers the NFL's marquee…
Media Release / Feb 28, 2025

Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU)

Two-year efficacy and safety data analyses from Phase III SUNSHINE and SUNRISE trials of continuous Cosentyx® (secukinumab) treatment in HS to be presented New analyses of 52-week…

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