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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Media 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… -
Media 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… -
Media 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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Media 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… -
Media 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)… -
Media 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… -
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… -
Media 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… -
Media Release
Sandoz targets growth opportunities in respiratory and complex generics through acquisition of respiratory device company Coalesce
Sandoz gains significant capabilities and assets in medical and drug device development that target major growth opportunities in respiratory and complex generics Respiratory diseases are leading… -
Media Release
Novartis data again demonstrate age-appropriate development when Zolgensma is used presymptomatically, and post-hoc data reveal SMA Type 1 patients could speak, swallow and maintain airway protection
Children with three copies of SMN2 treated presymptomatically achieved age-appropriate milestones, including standing and walking; required no ventilatory or feeding tube support; and had no serious…
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