Novartis

Novartis Kisqali® 5-year NATALEE data demonstrate 28% reduction in risk of recurrence in the broadest early breast cancer patient population

The five-year invasive disease-free survival (iDFS) rates were 85.5% in the Kisqali plus ET arm versus 81.0% in the ET alone arm, representing a clinically meaningful 4.5% improvement 1. These ...
Novartis

Novartis Fabhalta® (iptacopan) meets Phase III primary endpoint, slows kidney function decline in patients with IgA nephropathy (IgAN)

In APPLAUSE-IgAN final analysis, Fabhalta demonstrated statistically significant, clinically meaningful improvement in estimated glomerular filtration rate (eGFR) slope vs. placebo over two years 1 ...
Novartis

Novartis receives FDA Breakthrough Therapy designation for Scemblix® in 1L CML

Novartis announced that the FDA has granted Breakthrough Therapy designation to Scemblix® (asciminib) for the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic ...
Novartis

Sandoz Biologics License Application for proposed biosimilar denosumab accepted by US FDA

In the US alone, more than 10 million adults over age 50 are estimated to have osteoporosis, of whom more than 80% are women. 3 It is predicted that one in two of these women and one in four men will ...
Novartis

Novartis discontinues hydroxychloroquine clinical trial based on slow enrollment, remains committed to pandemic research efforts

Novartis will continue to provide supply of HCQ for ongoing investigator-initiated trials (IITs) and upon government requests, as appropriate, where certain conditions are met and the medicine is used ...
Novartis

Novartis receives FDA approval for Rhapsido® (remibrutinib), the only oral, targeted BTKi treatment for chronic spontaneous urticaria (CSU)

Ad hoc announcement pursuant to Art. 53 LR Rhapsido helps to inhibit release of histamine and proinflammatory mediators by targeting BTK, offering unique approach to CSU treatment1 Well-controlled ...
Novartis

Bringing breakthroughs to more patients

At Novartis, we don’t just discover life-changing medicines, we're part of a broader effort to help ensure medicines reach the people who need them most, wherever they live, because the true value of ...
Novartis

New Novartis data further support benefits of Kesimpta® in relapsing MS following switch from oral disease modifying therapies

ARTIOS Phase IIIb, open-label, single-arm, prospective study showed a substantial reduction in disease activity in people with relapsing multiple sclerosis (RMS) following switch to Kesimpta after ...
Novartis

Novartis ianalumab Phase III trial meets primary endpoint in ITP, demonstrating statistically significant improvement in time to treatment failure

Ianalumab prolonged the duration of safe platelet levels during and after treatment in patients with primary immune thrombocytopenia (ITP) previously treated with corticosteroids 1,2 Patients treated ...
Novartis

Novartis twice-yearly* Leqvio® (inclisiran) receives FDA approval for new indication enabling first-line use

Leqvio can now be used alone, without addition of statin therapy, as adjunct to diet and exercise for LDL-C reduction in patients with hypercholesterolemia (high LDL-C) 1 4 out of 5 atherosclerotic ...
Novartis

Novartis announces expiration of Regulus Therapeutics tender offer

. Novartis is providing the information in this press release as of this date and Novartis does not undertake any obligation to update any forward-looking statements contained in this press release as ...
Novartis

Novartis completes acquisition of Regulus Therapeutics

Basel, June 25, 2025 – Novartis today announced that it has successfully completed its acquisition of Regulus Therapeutics Inc. (“Regulus”). With the completion of the acquisition, shares of common ...