Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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January 2021
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Media Release
Novartis ligelizumab (QGE031) receives FDA Breakthrough Therapy designation for patients with chronic spontaneous urticaria (CSU)
Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria (CSU) in patients with an inadequate response to H1-antihistamines1 Currently… -
In The News
Pandemic has been a reset for pharma’s reputation
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Media Release
Novartis expands Oncology pipeline with in-licensing of tislelizumab from BeiGene
Agreement expands Novartis Oncology portfolio, adding late-stage PD-1 for monotherapy and potential proprietary PD-1 combinations, driving mid- and long-term growthNovartis secures development and… -
Story Patient Perspectives
Turning the sound up on patient voices in lung cancer research and development
Global Oncology Patient Insights Panels (GOPIPs) are giving patients and advocates a critical voice in advancing lung cancer trials.
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Story Patient Perspectives
AI Nurse evolving for heart failure patients in China
Improved versions of our new digital platform for heart failure disease management in China have been developed since April, 2020 rollout.
December 2020
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Key Release
Novartis receives complete response letter from U.S. FDA for inclisiran
The 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… -
Media Release
Novartis builds on commitment to addressing need in neuropsychiatric disorders with Cadent Therapeutics acquisition
The 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… -
Media Release
Novartis investigational oral therapy iptacopan (LNP023) receives FDA Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3G
Paroxysmal 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… -
Media Release
Novartis announces positive FDA Advisory Committee recommendation for use of Entresto® to treat patients with HFpEF
The 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… -
Media Release
Novartis reports positive topline results from second Phase III trial of Beovu® in patients with diabetic macular edema
In 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… -
Featured News
The 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 Release
Novartis provides update on RUXCOVID study of ruxolitinib for hospitalized patients with COVID-19
Phase 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…