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Showing 1793 results
December 2020
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Key ReleaseNovartis receives complete response letter from U.S. FDA for inclisiranThe U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related…
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Media ReleaseNovartis builds on commitment to addressing need in neuropsychiatric disorders with Cadent Therapeutics acquisitionThe agreement includes two clinical stage molecules for schizophrenia and movement disorders and MIJ821, a clinical stage molecule previously licensed exclusively by Novartis for addressing treatment…
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Media ReleaseNovartis investigational oral therapy iptacopan (LNP023) receives FDA Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3GParoxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, resulting in debilitating symptoms that can impact patients’ quality of life1–3C3 glomerulopathy (C3G) is a…
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Media ReleaseNovartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEFThe Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF)Potential Q1 2021 sNDA approval…
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Media ReleaseNovartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edemaIn Phase III KESTREL study, Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52)1In a…
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Featured NewsThe RUXCOVID clinical trial
The RUXCOVID clinical trial highlights the Novartis commitment to leverage our expertise and resources to support the global response to the COVID-19 pandemic.
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Media ReleaseNovartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19Phase III study did not meet its primary endpoint of reducing the number of hospitalized COVID-19 patients who experienced severe complications (death, mechanical ventilation or ICU care)1 Detailed…
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Media ReleaseNovartis receives EU approval for Leqvio®* (inclisiran), a first-in-class siRNA to lower cholesterol with two doses a year**Leqvio® (inclisiran) is the first and only approved small-interfering RNA (siRNA) low-density lipoprotein cholesterol (LDL-C) lowering treatment in Europe1-3 Cardiovascular disease causes 3.9…
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Media ReleaseNovartis Kisqali® data demonstrate superior benefit across main intrinsic subtypes in metastatic breast cancerFindings presented at SABCS from largest intrinsic subtype analysis show Kisqali is unique among CDK4/6 inhibitors, delivers consistent efficacy across main HR+/HER2- intrinsic subtypes1Benefit seen…
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Media ReleaseNovartis Kisqali® demonstrates nearly five years median overall survival in metastatic breast cancerMONALEESA-7 median overall survival (OS) results reinforce Kisqali as the CDK4/6 inhibitor with unrivaled OS evidence1Kisqali plus endocrine therapy had a median OS of nearly five years (58.7…
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Media ReleaseNovartis investigational STAMP inhibitor asciminib (ABL001) shows superior MMR rate to Bosulif®* in chronic myeloid leukemia trialAt 24 weeks, asciminib nearly doubled the major molecular response (MMR) rate compared to Bosulif® (bosutinib)*, in patients resistant to, or intolerant of, at least two prior tyrosine kinase…
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