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Ad hoc release / Dec 06, 2023

Novartis receives FDA approval for Fabhalta® (iptacopan), offering superior hemoglobin improvement in the absence of transfusions as the first oral monotherapy for adults with PNH

Ad hoc announcement pursuant to Art. 53 LR Approval based on APPLY-PNH trial in adults with PNH and anemia despite prior anti-C5 treatment, and supported by the APPOINT-PNH study in complement…
Press release / Apr 29, 2016

Novartis drug Afinitor® recommended by CHMP for European Union approval to treat select GI and lung neuroendocrine tumors

If approved, Afinitor would be first treatment in EU indicated for advanced progressive, nonfunctional lung NET and first oral therapy for this type of GI NET Advanced, progressive, nonfunctional…
Press release / Feb 26, 2016

FDA approves new indication for Novartis drug Afinitor® for progressive, nonfunctional GI and lung neuroendocrine tumors (NET)

In advanced progressive, nonfunctional NET, Afinitor is the first approved treatment for patients with lung NET and the first oral therapy for GI NET Approval helps fulfill unmet need as…
Press release / Dec 08, 2018

Novartis data demonstrates consistent efficacy and tolerability of Kisqali® combination therapy in HR+/HER2- advanced breast cancer in patients with difficult-to-treat visceral disease

Subgroup analyses of three pivotal Phase III MONALEESA trials showed Kisqali plus endocrine therapy extended PFS in all patients with and without visceral involvement compared to endocrine…
Ad hoc release / Mar 28, 2025

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

Ad hoc announcement pursuant to Art. 53 LR New indication approximately triples eligible patient population, allowing Pluvicto® to be used after one androgen receptor pathway inhibitor (ARPI)…
Press release / Dec 21, 2018

Novartis receives European Commission (EC) approval for expanded indication for Kisqali® (ribociclib)

Basel, December 21, 2018 - Novartis today announced that the European Commission (EC) approved an expanded indication for Kisqali® (ribociclib), the CDK4/6 inhibitor with the largest body of…
Ad hoc release / Oct 25, 2022

Novartis maintains growth momentum and confirms FY’22 Group guidance

Ad hoc announcement pursuant to Art. 53 LR Q3 sales grew +4% cc1 (-4% USD) Innovative Medicines (IM) sales grew +4% cc (-3% USD), driven by key growth brands including: Entresto (+31% cc),…
Press release / May 31, 2015

Combination of Novartis drugs Tafinlar® and Mekinist® shows significant survival benefit in patients with metastatic melanoma

Final analysis of COMBI-d confirms overall survival benefit of combination therapy in patients with BRAF V600E/K mutation-positive metastatic melanoma Tafinlar and Mekinist in combination…
Press release / Mar 22, 2024

Novartis Fabhalta® (iptacopan) receives positive CHMP opinion as first oral monotherapy for adult patients with paroxysmal nocturnal hemoglobinuria (PNH)

Positive CHMP opinion based on robust Phase III data, including APPLY-PNH, demonstrating superior hemoglobin improvement in the absence of transfusions with Fabhalta compared to anti-C5 therapy1-5 If…
Press release / Oct 16, 2019

Novartis announces that Jakavi® (ruxolitinib) meets primary endpoint in Phase III study of acute graft-versus-host disease

REACH2 trial results confirm Jakavi significantly improves overall response rate (ORR) at 28 days vs. best available therapy in steroid-refractory acute graft-versus-host disease (GvHD)[1] GvHD…

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