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Ad hoc release / Nov 10, 2017

Novartis brolucizumab (RTH258) demonstrates superiority versus aflibercept in key secondary endpoint measures of disease activity in nAMD, a leading cause of blindness

Brolucizumab, the first and only anti-VEGF to maintain a majority of patients on a 12-week treatment schedule immediately following loading phase in Phase III trials, met primary endpoint of non-…
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…
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 02, 2018

New Novartis data presented at ASCO find nearly half of CML patients treated with Tasigna® remain in remission almost three years after stopping therapy

ENESTop and ENESTfreedom data evaluate Treatment-free Remission (TFR) rates at 144 weeks among eligible Ph+ CML-CP patients who stopped Tasigna® Findings further support durability and…
Ad hoc release / Oct 08, 2019

Novartis receives FDA approval for Beovu®, offering wet AMD patients vision gains and greater fluid reductions vs aflibercept

In two head-to-head clinical trials, patients on Beovu (brolucizumab) achieved vision gains that were non-inferior to aflibercept at year one with longer treatment intervals in a majority of…
Press release / Jun 26, 2020

Novartis receives positive CHMP opinion for new Xolair® indication to treat severe chronic rhinosinusitis with nasal polyps

If approved, Xolair® (omalizumab) will provide patients who have severe chronic rhinosinusitis with nasal polyps, not adequately controlled by intranasal corticosteroids, with the first anti-…
Press release / Jun 11, 2020

US FDA approves updated Novartis Beovu® label, to include additional safety information

Novartis worked with US Food and Drug Administration (FDA) to update Beovu (brolucizumab) prescribing information to guide healthcare professionals in their treatment of wet AMD patients1 The…
Press release / Jun 05, 2020

Novartis Phase IIIb ARGON study meets primary endpoint in a comparison of Enerzair® Breezhaler® (QVM149) versus a free combination of two existing inhaled treatments in uncontrolled asthma

Once-daily Enerzair® Breezhaler® (QVM149; IND/GLY/MF) met primary endpoint, demonstrating non-inferiority to a free combination of twice-daily Sal/Flu plus once-daily tiotropium (Tio), in improving…
Press release / May 27, 2020

Novartis Kisqali® shows overall survival benefit in HR+/HER2- advanced breast cancer with consistent findings in patients with more aggressive disease

New MONALEESA-7 (M7) and MONALEESA-3 (M3) subgroup analysis to be presented during ASCO20 Virtual Scientific Program Subgroup analysis shows Kisqali plus endocrine therapy extended life…
Ad hoc release / May 06, 2020

Novartis announces FDA approval of MET inhibitor Tabrecta™ for metastatic non-small cell lung cancer with METex14

Tabrecta (capmatinib, formerly INC280) is the first and only therapy approved by the FDA to specifically target metastatic NSCLC with a mutation that leads to MET exon 14 skipping (METex14)…

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