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Press release / Jul 06, 2017

Novartis receives approval in the EU for Cosentyx label update, includes long term superiority data versus Stelara in psoriasis

Label update includes 52 week data from CLEAR study demonstrating long-term superiority of Cosentyx® versus Stelara® in psoriasis [1],[2] Update also includes use of Cosentyx in moderate-to…
Press release / Dec 10, 2018

Sandoz Inc. and Pear Therapeutics Obtain FDA Clearance for reSET-O(TM) to Treat Opioid Use Disorder

reSET-OTM is the first FDA-cleared Prescription Digital Therapeutic (PDT) for patients with Opioid Use Disorder Pear Therapeutics is leading the development of a new therapeutic class with two…
Ad hoc release / Mar 28, 2025

FDA approves Novartis radioligand therapy Pluvicto® for earlier use before chemotherapy in PSMA-positive metastatic castration-resistant prostate cancer

Ad hoc announcement pursuant to Art. 53 LR New indication approximately triples eligible patient population, allowing Pluvicto® to be used after one androgen receptor pathway inhibitor (ARPI)…
Press release / Nov 12, 2025

Novartis Phase III trial for next-generation malaria treatment KLU156 (GanLum) meets primary endpoint, with potential to combat antimalarial resistance

Phase III trial for KLU156 (ganaplacide/lumefantrine, or GanLum), meets primary endpoint of non-inferiority to standard of care Coartem® (artemether-lumefantrine) Demonstrates PCR-corrected cure rate…
Press release / Nov 23, 2015

Novartis receives two landmark European approvals for Cosentyx to treat patients with ankylosing spondylitis and psoriatic arthritis

Cosentyx is the first and only IL-17A inhibitor from a new class of medicines shown to treat two of the most common inflammatory joint conditions in Europe[1] Cosentyx shows rapid and…
Press release / Aug 24, 2017

Novartis Kisqali® (ribociclib) receives EU approval as first-line treatment for HR+/HER2- locally advanced or metastatic breast cancer in combination with any aromatase inhibitor

Approval is based on pivotal MONALEESA-2 trial, which showed Kisqali plus letrozole reduced risk of disease progression or death by 43% versus letrozole alone[1] Kisqali plus letrozole…
Press release / Jan 16, 2018

Novartis new data reinforces superiority of Cosentyx® versus Stelara®* in achieving skin clearance for psoriasis patients

Results from CLARITY study show Cosentyx® (secukinumab) was significantly more effective than Stelara®* (ustekinumab) in delivering clear and almost clear skin at 12 weeks and at 16 weeks[1]…
Press release / Jan 03, 2018

Novartis Kisqali® received FDA Breakthrough Therapy designation for initial endocrine-based treatment in premenopausal women with HR+/HER2- advanced breast cancer

Designation based on Phase III MONALEESA-7 results demonstrating superior efficacy of Kisqali in combination with oral endocrine therapy compared to oral endocrine therapy in pre- or perimenopausal…
Press release / Nov 14, 2016

Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis

Priority Review based on data from the largest clinical trials conducted to date in each indication[1],[2] Designation will shorten FDA expected review time to within six months[3]; EMA also…
Press release / Oct 30, 2017

Novartis to present first of its kind evidence for Cosentyx® on potential to maintain mobility in patients with AS and PsA

Long-term 4-year data in ankylosing spondylitis (AS) and 24-weeks data in psoriatic arthritis (PsA) to be presented at the 2017 ACR/ARHP Annual Meeting[1],[2] Structural disease progression is a…

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