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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 / 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 / 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 / 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 / Oct 18, 2024

Novartis receives positive CHMP opinion for Kisqali® to help reduce risk of recurrence in people with HR+/HER2- early breast cancer

If approved, patients in Europe with stage II or III HR+/HER2- early breast cancer (EBC) at high risk of recurrence, including those with node-negative disease, will be eligible for adjuvant…
Media Release / May 31, 2024

Latest analysis of Novartis NATALEE study shows Kisqali® reduces risk of cancer recurrence for early breast cancer patients with high-risk node-negative disease

Addition of Kisqali® (ribociclib) to endocrine therapy (ET) demonstrated a 28% risk reduction in invasive disease-free survival (iDFS) in subgroup of patients with node-negative (N0) disease…
Media Release / May 25, 2024

Novartis atrasentan Phase III data show clinically meaningful proteinuria reduction further advancing company's IgA nephropathy (IgAN) portfolio

In the ALIGN study, atrasentan, in addition to supportive care with a renin-angiotensin system (RAS) inhibitor, demonstrated a statistically significant 36.1% proteinuria (protein in urine)…
Media Release / Sep 18, 2024

New Novartis data in relapsing MS reinforce benefits of Kesimpta® for first-line and switch patients

Nearly 90% of first-line Kesimpta patients had no disability progression independent of relapse activity (PIRA) for up to six years in an analysis of open-label ALITHIOS extension study1 More than…

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