Key Releases are ad hoc announcements pursuant to SIX Swiss Exchange Article 53 Listing Rules.
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April 2022
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Press Release
FDA approves Novartis Vijoice® (alpelisib) as first and only treatment for select patients with PIK3CA-Related Overgrowth Spectrum (PROS)
Vijoice is first approved treatment to specifically address the root cause of PROS conditions in select patients 2 years of age and older1 PROS is a spectrum of rare conditions and is… -
Press Release
Novartis presents new four-year data on efficacy and safety of Kesimpta® (ofatumumab) in people living with relapsing multiple sclerosis
Phase 3 ASCLEPIOS I/II trials and the ALITHIOS open-label extension demonstrated the efficacy and safety of continuous Kesimpta® (ofatumumab) treatment and in those switched from teriflunomide, with… -
Press Release
Novartis expands Zolgensma manufacturing capacity with approval of multi-product North Carolina facility
Clearance of critical milestone expands capability for production of gene therapies, starting with Zolgensma® Basel, April 5, 2022 – Novartis today announced the U.S. Food and Drug Administration (… -
Key Release
Novartis announces new organizational structure to accelerate growth, strengthen pipeline and increase productivity
Ad hoc announcement pursuant to Art. 53 LRNew simplified structure and operational set-up supports Novartis strategy as a focused medicines company and is designed to power next phase of… -
Key Release
Novartis gibt neue Organisationsstruktur bekannt für schnelleres Wachstum, eine stärkere Pipeline und höhere Produktivität
Ad-hoc-Mitteilung gemäss Art. 53 KRDie neue, vereinfachte Struktur und Organisation werden die Strategie von Novartis als fokussiertes Arzneimittelunternehmen unterstützen und die nächste Phase…
March 2022
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Press Release
Novartis announces European Commission approval of Beovu® for people living with diabetic macular edema
Diabetic macular edema (DME) is a leading cause of blindness in adults in developed countries; unmet needs in DME include improving fluid resolution in the retina and addressing the burden of… -
Press Release
Novartis receives positive CHMP opinion for Jakavi® to treat acute and chronic graft-versus-host disease
CHMP opinion based on Phase III REACH2 and REACH3 trials that showed Jakavi improved response rates and failure-free survival compared to best available therapy1,2 Graft-versus-host disease (GvHD)… -
Press Release
Novartis receives positive CHMP opinion for Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe
Positive opinion paves way for third indication in Europe for Kymriah, a potentially definitive single infusion CAR-T cell therapy treatment optionCHMP opinion based on Phase II global ELARA trial… -
Understanding hidradenitis suppurativa through Jasmine’s eyes
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Key Release
Novartis Pluvicto™ approved by FDA as first targeted radioligand therapy for treatment of progressive, PSMA positive metastatic castration-resistant prostate cancer
Ad hoc announcement pursuant to Art. 53 LR FDA also approved complementary diagnostic imaging agent, Locametz®, after radiolabeling with gallium-68 for the identification of PSMA-positive… -
Statement
Novartis condemns the war in Ukraine - update March 22
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Press Release
New peer-reviewed research shows no increased risk of serious COVID-19 infections in Kesimpta® (ofatumumab)-treated adults with multiple sclerosis
The study published in ‘Neurology and Therapy’ also shows the fatal outcomes and hospitalization rates due to COVID-19 in those treated with Kesimpta were in line with the rates in the general MS…
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