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Press release / Aug 27, 2017

Novartis announces analysis published in The Lancet showing ACZ885 reduced lung cancer mortality by 77% in the CANTOS study with further studies planned

Review of blinded, pre-planned oncology safety analyses revealed a 77% reduction in lung cancer mortality and 67% reduction in lung cancer cases in patients treated with 300mg of ACZ885 CANTOS is…
Press release / Nov 27, 2024

Novartis Kisqali® receives European Commission approval in a broad population of patients with HR+/HER2- early breast cancer at high risk of recurrence

Approval is based on Phase III NATALEE data showing Kisqali® (ribociclib) plus adjuvant endocrine therapy (ET) demonstrated clinically meaningful invasive disease-free survival (iDFS) benefit in…
Press release / Oct 14, 2021

Kesimpta® (ofatumumab) data at ECTRIMS highlights preservation of IgG levels and safety experience over extended exposure (~3.5 years) in people living with relapsing multiple sclerosis

ALITHIOS Phase IIIb open-label extension study data based on ~3.5 years of exposure demonstrated that mean immunoglobulin G (IgG) levels in patients treated with Kesimpta remained stable, and there…
Ad hoc release / Sep 17, 2024

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

Ad hoc announcement pursuant to Art. 53 LR Broad indication in HR+/HER2- stage II and III early breast cancer (EBC) at high risk of recurrence approximately doubles population eligible for CDK4…
Press release / Mar 22, 2018

Novartis drug Tasigna® approved by FDA to treat children with rare form of leukemia

Tasigna® (nilotinib) approved for pediatric patients with newly diagnosed Ph+ CML-CP and children with Ph+ CML-CP resistant or intolerant to prior TKI therapy New indication approved under FDA…
Press release / Apr 25, 2017

Novartis delivered sales growth across all divisions (cc1) as growth drivers, including Cosentyx and Entresto, more than offset generic erosion; innovation momentum continued

Net sales grew 2% (cc, -1% USD), as growth drivers more than offset Gleevec/Glivec impact Cosentyx (USD 410 million, +136% cc) showing strong growth in all three indications Entresto (USD 84…
Press release / Nov 05, 2019

Sandoz receives US FDA approval for long-acting oncology supportive care biosimilar Ziextenzo™ (pegfilgrastim-bmez)

Ziextenzo™ is indicated to decrease the incidence of febrile neutropenia, one of the most serious side effects of chemotherapy With approval of Ziextenzo™ , Sandoz is first and only…
Ad hoc release / Sep 30, 2025

Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)

Ad hoc announcement pursuant to Art. 53 LR Rhapsido helps to inhibit release of histamine and proinflammatory mediators by targeting BTK, offering unique approach to CSU treatment1Well-controlled…
Press release / Jul 01, 2023

Sandoz to launch Hyrimoz® (adalimumab-adaz) high-concentration formulation, marking Sandoz entrance into US immunology space

Hyrimoz® (adalimumab-adaz) high-concentration formulation (HCF) biosimilar offers US patients reduced injection volume in citrate-free formulationAs one of the only adalimumab HCF biosimilars…
Press release / May 15, 2024

Novartis highlights pioneering innovation in CML with data from Scemblix® Phase III ASC4FIRST study in newly diagnosed patients at ASCO and EHA

Primary results of the Scemblix® ASC4FIRST pivotal Phase III study in first-line Ph+ CML-CP supporting third US FDA Breakthrough Therapy designation, to be detailed in the ASCO Press Program and the…

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