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Press release / Sep 18, 2015

Swissmedic approves Novartis' new heart failure medicine Entresto(TM)

Decision by Swiss Health Authority follows US Food and Drug Administration (FDA) approval of Entresto in July, serves as an important reference approval for multiple other health authorities…
Press release / Feb 24, 2017

Novartis receives positive CHMP opinion for Tafinlar® + Mekinist® in BRAF-positive non-small cell lung cancer (NSCLC) patients

If approved, Tafinlar + Mekinist will be the first targeted therapy specifically for NSCLC patients with a BRAF V600 mutation CHMP opinion based on positive data from pivotal study of patients…
Press release / Jul 27, 2018

Novartis combination Tafinlar® + Mekinist® receives positive CHMP opinion for adjuvant treatment of BRAF V600 mutation-positive melanoma

Phase III trial showed a 53% reduction in risk of recurrence or death with the combination of a BRAF and MEK inhibitor as adjuvant therapy versus placebo[1] Relapse-free survival benefit with…
Press release / Feb 28, 2025

Novartis oral Fabhalta® (iptacopan) receives positive CHMP opinion for the treatment of adults living with C3 glomerulopathy (C3G)

If approved, Fabhalta® will be the only medicine indicated to selectively target the underlying cause of C3G1, an ultra-rare, progressive kidney disease with no currently approved treatments2-5…
Ad hoc release / Mar 27, 2019

Novartis receives FDA approval for Mayzent® (siponimod), the first oral drug to treat secondary progressive MS with active disease

Mayzent® (siponimod) is the first and only treatment specifically approved for patients with active secondary progressive multiple sclerosis (SPMS) in over 15 years[1] Up to 80% of patients…
Press release / Jul 24, 2020

Novartis Adakveo® receives positive CHMP opinion for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease

If approved, Adakveo would be the first targeted sickle cell disease therapy available for use in Europe CHMP opinion supported by data showing Adakveo significantly reduced the rate of vaso-…
Press release / May 19, 2017

Novartis receives positive CHMP opinion for first-line use of Zykadia® in ALK-positive advanced non-small cell lung cancer (NSCLC)

Phase III trial, first-line treatment with Zykadia resulted in improved progression-free survival (PFS) over SOC chemotherapy with maintenance, including in patients with brain metastases[1]…
Ad hoc release / Jun 29, 2018

Novartis receives positive CHMP opinion for Kymriah® for treating two aggressive blood cancers, marking important medical advance for patients in Europe

First CHMP opinion for a CAR-T cell therapy in two distinct indications - DLBCL in adults and B-cell ALL in children Marketing Authorization Application (MAA) based on landmark global CAR-T…
Press release / Jun 04, 2017

Novartis landmark study of Tafinlar® + Mekinist® demonstrates durable survival benefit at five years in patients with BRAF mutation-positive metastatic melanoma

Study is longest follow-up to date of a BRAF and MEK inhibitor combination therapy in patients with BRAF V600-mutant metastatic melanoma[1] Study shows stable overall survival and progression-free…
Ad hoc release / Oct 27, 2020

Novartis im 3. Qu. mit solider Performance: operatives Kernergebnis steigt um 11%, Nettoumsatz auf Vorjahresniveau, starke Pipeline-Fortschritte; Jahresprognose für operatives Kernergebnis angehoben

Im dritten Quartal 2020 lag der Nettoumsatz der fortzuführenden Geschäftsbereiche1 auf dem Niveau des Vorjahres (kWk2, +1% USD): Zu den Wachstumsträgern gehörten Entresto (USD 632 …