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Press release / Nov 06, 2017

Novartis reaches another regulatory milestone for CTL019 (tisagenlecleucel) with submission of its MAA* to EMA for children, young adults with r/r B-cell ALL and adult patients with r/r DLBCL

Application follows sBLA submission to the FDA for r/r DLBCL which marked second US application for first-ever FDA approved CAR-T therapy Building on the US r/r B-cell ALL experience, Novartis…
Press release / Mar 17, 2015

Novartis receives EU approval for Jakavi® in polycythemia vera, first targeted therapy approved for patients with this rare blood cancer

Jakavi® (ruxolitinib) approved by the European Commission for adult patients with polycythemia vera (PV) resistant to or intolerant of hydroxyurea PV is a rare blood cancer associated with…
Press release / Jul 30, 2018

Novartis marks a new era for migraine patients with the EU approval of Aimovig®, a first-of-its-kind treatment specifically designed for migraine prevention

Patients on Aimovig (erenumab) in clinical trials reported consistent and sustained migraine prevention, with many experiencing a 50% or more reduction in monthly migraine days; safety and…
Press release / Jun 11, 2015

Novartis gains FDA approval for Promacta® providing new option for children, ages 6 and older, with chronic ITP, a rare blood disorder

Promacta® (eltrombopag) significantly increased and sustained platelet counts in two studies, including the largest Phase III clinical trial in this patient population Characterized by a low…
Press release / Jan 30, 2018

AveXis to Initiate Screening for Remaining Patients in Pivotal Trial of AVXS-101 for SMA Type 1 Following Review of Preliminary Data from First Three Patients

CHICAGO, Jan. 30, 2018 (GLOBE NEWSWIRE) -- AveXis, Inc. (NASDAQ:AVXS), a clinical-stage gene therapy company developing treatments for patients suffering from rare and life-threatening…
Press release / Jul 21, 2017

Novartis receives positive CHMP opinion for Rydapt® (midostaurin) for newly diagnosed FLT3-mutated acute myeloid leukemia (AML) and three types of advanced systemic mastocytosis (SM)

Recommendation based on largest trial in FLT3-mutated AML to date, showing 23% reduction in the risk of death with Rydapt treatment regimen[1] If approved, Rydapt would represent the first…
Press release / Sep 01, 2015

Novartis receives EU approval for Tafinlar® and Mekinist®, first combination approved for patients with aggressive form of melanoma

Approval based on two Phase III studies demonstrating statistically significant overall survival benefit with combination therapy vs BRAF inhibitor monotherapy Targeted combination offers…
Press release / Aug 30, 2017

Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice

First-in-class therapy showed an 83% (52/63) overall remission rate in this patient population with limited treatment options and historically poor outcomes [1],[2]. Novel approach to cancer…
Press release / Apr 24, 2026

Novartis receives positive CHMP opinion for Itvisma® for spinal muscular atrophy (SMA)

If approved, Itvisma (intrathecal onasemnogene abeparvovec) will be first and only gene replacement therapy for children two years and older, teens and adults with SMA in the European UnionItvisma…
Ad hoc release / Nov 24, 2025

Novartis receives FDA approval for Itvisma®, the only gene replacement therapy for children two years and older, teens, and adults with spinal muscular atrophy (SMA)

Ad hoc announcement pursuant to Art. 53 LR Itvisma (onasemnogene abeparvovec-brve) demonstrated improved motor function and stabilization in patients regardless of SMA treatment history in Phase III…

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