Global Search

Hide Filters

Showing 1672 results

Press release / Apr 22, 2022

Novartis receives positive CHMP opinion for Tabrecta® for patients with METex14 advanced non-small cell lung cancer

Opinion based on Phase II GEOMETRY mono-1 study showing an overall response rate (ORR) of 51.6% in a cohort evaluating second-line patients only and 44% in all previously-treated patients with…
Press release / Apr 11, 2022

Novartis announces early clinical data for unique KRASG12C inhibitor at American Association for Cancer Research annual meeting

JDQ443, an investigational selective, covalent, and orally bioavailable KRASG12C inhibitor, shows 57% confirmed ORR at recommended dose of 200 mg twice daily in Phase Ib study in patients with…
Press release / Oct 31, 2017

Novartis submits application to FDA for KymriahTM (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy

Submission based on updated analyses from global, multi-center Phase II JULIET study, which met primary endpoint, including 6-month data to be presented at ASH 2017 Kymriah has demonstrated…
Press release / Jan 17, 2018

Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL

Filing acceptance marks second Priority Review granted to Kymriah by the FDA for two distinct indications, underscoring the potential of first ever FDA-approved CAR-T therapy EMA granted…
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 / 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 / Jul 07, 2020

Novartis receives EC approval for Enerzair® Breezhaler®, including the first digital companion (sensor and app) that can be prescribed alongside a treatment for uncontrolled asthma in the EU

European Commission approves once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) in the EU, the first-in-class LABA/LAMA/ICS fixed-dose combination for patients whose asthma is uncontrolled with…
Press release / Nov 16, 2018

FDA approves Novartis drug Promacta® for first-line SAA and grants Breakthrough Therapy designation for additional new indication

Promacta receives FDA approval for first-line treatment of severe aplastic anemia (SAA) and Breakthrough Therapy designation for low platelet counts in people exposed to radiation Approval…
Press release / Nov 15, 2019

Novartis receives positive CHMP opinion for Mayzent® (siponimod) for the treatment of adult patients with active secondary progressive multiple sclerosis (SPMS)

If approved, Mayzent® (siponimod) will be the first and only oral treatment specifically indicated for patients with active secondary progressive multiple sclerosis (SPMS) in Europe[1]) CHMP…

‹ Previous page
1
…
8
9
10
11
12
13
14
…
168
› Next page