Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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Showing 1196 results
December 2021
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Key ReleaseFDA approves Novartis Leqvio® (inclisiran), first-in-class siRNA to lower cholesterol and keep it low with two doses a yearAd hoc announcement pursuant to Art. 53 LR With two maintenance doses a year, Leqvio is the first and only FDA-approved small interfering RNA (siRNA) therapy for LDL-C (bad cholesterol…
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Media ReleaseNovartis to acquire Gyroscope Therapeutics, adding a one-time gene therapy that could transform care for geographic atrophy, a leading cause of blindnessThere are no currently approved therapies impacting disease progression for the up to 8 million people suffering from geographic atrophy (GA)1,2 Acquisition will add GT005 to the Novartis portfolio…
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Media ReleaseSandoz submits Marketing Authorization Application for proposed biosimilar trastuzumab to EMASubmission is supported by comprehensive package of analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix, Inc.Breast cancer is one of most common types of…
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Media ReleaseSandoz submits Biologics License Application for proposed biosimilar trastuzumab to US FDABiologics License Application (BLA) is supported by analytical, pre-clinical and clinical data, proposed biosimilar trastuzumab developed by EirGenix, Inc. Trastuzumab is monoclonal…
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Media ReleaseNovartis strengthens immunotherapy pipeline with option, collaboration and license agreement with BeiGene for TIGIT inhibitor ociperlimabOciperlimab adds innovative and complementary late-stage TIGIT inhibitor to an Oncology portfolio poised for growth Two Phase III trials underway in non-small cell lung cancer and additional studies…
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Key ReleaseNovartis provides an update on Phase III ligelizumab (QGE031) studies in chronic spontaneous urticaria (CSU)Ad hoc announcement pursuant to Art. 53 LR Ligelizumab, a high-affinity anti-IgE antibody, demonstrated superiority compared with placebo at Week 12 in Phase III PEARL 1 and…
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Key ReleaseNovartis initiates new USD 15 billion share buyback highlighting confidence in growth and pipelineAd hoc announcement pursuant to Art. 53 LR Share buyback of up to USD 15bn planned to be executed by end 2023, highlighting confidence in top line growth and deep pipelineSales expected to grow…
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Media ReleaseNovartis announces T-Charge™, next-generation CAR-T platform with first-in-human data at ASH 2021T-Charge, a next-generation platform that aims to revolutionize CAR-T cell therapy, will serve as foundation for various investigational CAR-T therapies Early data from first-in-human dose-…
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Media ReleaseNovartis Scemblix® demonstrates sustained response rate in 48-week follow-up in patients with chronic myeloid leukemiaUpdated 48-week data from Phase III ASCEMBL trial consistent with improved major molecular response (MMR) rate of Scemblix® (asciminib) vs. Bosulif®* (bosutinib) and lower discontinuation rate due to…
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Media ReleaseNovartis Kymriah® demonstrates strong responses in high-risk patients with relapsed or refractory follicular lymphoma in extended study follow-upComplete and overall response rates and durability of response were well maintained across majority of high-risk subgroups with a significant unmet need1 Median follow-up of approximately 17 months…
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Media ReleaseNovartis data highlight efficacy of Piqray® in HR+/HER2- metastatic breast cancer with a PIK3CA driver mutation immediately post-CDK4/6iNew data underscore efficacy of Piqray, even in those patients with a short treatment duration on prior CDK4/6i or with ESR1 mutations, biomarkers of endocrine resistance1-5 Recent guideline…
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Media ReleaseNovartis announces positive results from year two of the Phase III trial of Beovu® in diabetic macular edemaResults from year two of the Phase III KESTREL clinical trial confirmed year one findings, with an overall favorable benefit-risk profile for Beovu® (brolucizumab) 6 mg in patients with visual…
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