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

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 Cosentyx® (secukinumab) receives positive CHMP opinion for expanded use in childhood arthritic conditions

Basel, May 20, 2022 — Novartis today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Cosentyx ® ...
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 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

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 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 ...
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 ...
Novartis

Novartis to acquire Regulus Therapeutics and farabursen, an investigational microRNA inhibitor to treat ADPKD, the most common genetic cause of renal failure

Regulus is a clinical-stage biopharmaceutical company developing microRNA therapeutics with a focus on autosomal dominant polycystic kidney disease (ADPKD), a severe renal disease Lead asset for ADPKD ...
Novartis

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

New indication approximately triples eligible patient population, allowing Pluvicto ® to be used after one androgen receptor pathway inhibitor (ARPI) and now before chemotherapy Pluvicto significantly ...
Novartis

New Novartis Phase III data demonstrate meaningful efficacy and safety results of intrathecal onasemnogene abeparvovec in broad patient population with SMA

Basel, March 19, 2025 – Novartis announced positive safety and efficacy results from the Phase III program for investigational intrathecal onasemnogene abeparvovec (OAV101 IT) in a broad population of ...