Novartis

PSMAddition data show Novartis Pluvicto™ delays progression to end-stage prostate cancer

PluvictoTM plus standard of care (ARPI + ADT) significantly reduced risk of progression or death by 28% (HR 0.72) versus SoC alone, with positive trend in OS (HR 0.84) in PSMA+ metastatic ...
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)

GFR is key marker of kidney function; IgAN is progressive autoimmune kidney disease that leads to kidney failure in many patients 1-3 Fabhalta is first and only approved complement inhibitor for ...
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 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 treatmen ...
Novartis

Novartis to showcase transformative data in advanced prostate and early breast cancer at ESMO 2025

Key data from PSMAddition has been selected for a Presidential session; data to showcase the efficacy and safety of PluvictoTM plus standard of care (SoC) versus SoC alone in PSMA+ mHSPC NATALEE ...
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 to acquire Tourmaline Bio, complementing cardiovascular pipeline with pacibekitug for the treatment of atherosclerotic cardiovascular disease (ASCVD)

Tourmaline Bio is a clinical-stage biopharmaceutical company developing pacibekitug, an anti-IL-6 mAb, as a treatment option for atherosclerotic cardiovascular disease Pacibekitug is a promising ...
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 Pluvicto™ demonstrates statistically significant and clinically meaningful rPFS benefit in patients with PSMA-positive metastatic hormone-sensitive prostate cancer

Novartis is investigating a broad portfolio of RLTs in advanced cancers, including breast, colon, lung and pancreatic and is investing in multiple manufacturing facilities, with industry-leading ...