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Press release / Dec 16, 2020

Novartis investigational oral therapy iptacopan (LNP023) receives FDA Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3G

Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, resulting in debilitating symptoms that can impact patients’ quality of life1–3C3 glomerulopathy (C3G) is a…
Press release / Jun 22, 2017

Novartis combination targeted therapy Tafinlar® + Mekinist® receives FDA approval for BRAF V600E mutant metastatic non-small cell lung cancer (NSCLC)

Approval provides first targeted treatment in the US specifically for BRAF V600E mutation-positive metastatic NSCLC More than 60% of treatment-naïve and previously treated patients with…
Pulse Update / Jun 16, 2021

Novartis receives FDA Breakthrough Therapy designation for investigational 177Lu-PSMA-617 in patients with metastatic castration-resistant prostate cancer (mCRPC)
Press release / Dec 02, 2021

Novartis R&D day spotlights attractive growth profile, underpinned by strong in-market brands, 20 potential high value pipeline assets, and technology platforms

Focused medicines company delivering strong operational performanceBuilding depth in five core therapeutic areas, strength in technology platforms, and a balanced geographic footprint Confident to…
Press release / Feb 28, 2025

Novartis data presentations at AAAAI and AAD underscore commitment to advancing treatment of hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU)

Two-year efficacy and safety data analyses from Phase III SUNSHINE and SUNRISE trials of continuous Cosentyx® (secukinumab) treatment in HS to be presentedNew analyses of 52-week data from Phase III…
Press release / Dec 12, 2016

Novartis provides update on pegpleranib Phase III clinical trial program in patients with neovascular age-related macular degeneration (nAMD or wet AMD)

Two pivotal Phase III studies did not show additional improvement in best corrected visual acuity (BCVA) for pegpleranib and Lucentis (ranibizumab) combination treatment over standard of care…
Press release / Jun 03, 2021

Novartis reports clinically relevant improvement in median overall survival data in final analysis of pivotal NETTER-1 study with targeted radioligand therapy Lutathera

At final analysis, study showed clinically relevant improvement in median overall survival with a difference of 11.7 months between arms (Hazard ratio (HR): 0.84 with 95% CI: (0.60, 1.17) (p=0.30,…
Press release / Mar 17, 2023

Novartis Tafinlar + Mekinist approved by FDA for pediatric patients with BRAF V600E low-grade glioma, the most common pediatric brain cancer

New approval based on TADPOLE trial showing overall response rate (ORR) of 47% and median progression-free survival (mPFS) of 20.1 months for Tafinlar + Mekinist compared to 11% ORR and 7.4 months…
Ad hoc release / Jul 07, 2023

Novartis will appeal to U.S. Court of Appeals to uphold validity of Entresto® combination patent; maintains 2023 guidance and mid-term outlook

Ad hoc announcement pursuant to Art. 53 LR U.S. District Court for the District of Delaware ruled the Entresto (sacubitril / valsartan) ‘combination patent’ to be invalid Novartis will appeal…
Pulse Update / Sep 28, 2021

FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)

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