The Novartis Rhapsido FDA approval makes remibrutinib the first approved treatment for adults with symptomatic dermographism not controlled by H1 antihistamines. It builds on Rhapsido’s existing chronic spontaneous urticaria indication.
Novartis has received a positive CHMP opinion recommending European marketing authorization for Cosentyx (secukinumab) in adults with polymyalgia rheumatica, based on Phase III REPLENISH data showing sustained remission and steroid-sparing effects.
Three major drugmakers disclosed missed primary endpoints within days of each other in September 2026 — here’s what went wrong, who it affects, and what it signals about pharma R&D.
Novartis announced pelacarsen Lp(a)HORIZON trial results on September 4, 2026, revealing that the Phase III cardiovascular outcomes study did not meet its primary endpoint, even though the investigational therapy lowered Lp(a) levels in more than 8,300 patients with established cardiovascular disease.
Novartis Q2 2026 results show a return to sales growth, with net sales up 3% to $14.4 billion on strong demand for Kisqali, Kesimpta, Scemblix, and Pluvicto, as the company reaffirmed its full-year 2026 guidance and advanced key pipeline programs including Fabhalta and Rhapsido.
The FDA has granted traditional approval to Novartis’ Fabhalta (iptacopan) — the first complement inhibitor shown to significantly slow kidney function decline in adults with primary IgA nephropathy. Phase III APPLAUSE-IgAN data showed a 48% slower eGFR decline versus placebo over two years.
Novartis has announced a definitive agreement to acquire UK-based biotechnology firm Myricx Bio for USD 1.1 billion upfront plus USD 400 million in milestones, gaining a breakthrough NMTi payload platform targeting solid tumors.
Marking a major milestone, Novartis receives European Commission approval for Itvisma, introducing a fixed, one-time gene replacement therapy for a broad population of spinal muscular atrophy patients across Europe
Novartis announced impressive 144-week data for its groundbreaking STAMP inhibitor, showcasing widening superior molecular response rates and better tolerability compared to standard TKIs in newly diagnosed CML patients.
Novartis has announced groundbreaking results from the Phase III PSMAddition trial, revealing that Pluvicto significantly reduces the risk of PSA progression by 58% in patients with metastatic hormone-sensitive prostate cancer.
