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 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

Novartis to launch Direct-to-Patient platform for Cosentyx® (secukinumab) in the US

Select units of Cosentyx to be made available at 55% discount off list price on direct-to-patient (DTP) platform beginning November 1, 2025 DTP offering to expand to other appropriate products; ...
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 announces both ianalumab Phase III clinical trials met primary endpoint in patients with Sjögren’s disease

Ad hoc announcement pursuant to Art. 53 LR NEPTUNUS-1 and NEPTUNUS-2 are the first ever global phase III trials to demonstrate statistically significant reduction in disease activity for Sjögren’s ...
Novartis

Novartis receives approval for first malaria medicine for newborn babies and young infants

Rapid approvals in eight African countries now expected under a special global health scheme run by Swiss agency for therapeutic products (Swissmedic) Novartis plans to introduce infant-friendly ...