Dear SMA community,One year ago we launched a global Managed Access Program (MAP), the first for a one-time gene therapy, to make Zolgensma® (onasemnogene abeparvovec) available to eligible patients with spinal muscular atrophy (SMA) who are under the …
Ligelizumab is the first treatment to receive FDA Breakthrough Therapy designation in chronic spontaneous urticaria (CSU) in patients with an inadequate response to H1-antihistamines1 Currently there are limited approved therapies for patients with CSU…
Agreement expands Novartis Oncology portfolio, adding late-stage PD-1 for monotherapy and potential proprietary PD-1 combinations, driving mid- and long-term growthNovartis secures development and commercialization rights in North America, Europe, and …
Dozens of improved versions of our new digital platform for heart failure disease management in China have been developed since roll-out a few months ago.Why? Because the digital product team in Novartis China has quickly learned from user feedback – e…
The U.S. Food and Drug Administration (FDA) has not raised any concerns related to the efficacy or safety of inclisiran. The complete response letter is due to unresolved facility inspection-related conditionsNo onsite inspection was conducted of the s…
The agreement includes two clinical stage molecules for schizophrenia and movement disorders and MIJ821, a clinical stage molecule previously licensed exclusively by Novartis for addressing treatment-resistant depression.The deal builds on Novartis exp…
Paroxysmal nocturnal hemoglobinuria (PNH) is a rare and life-threatening blood disorder, resulting in debilitating symptoms that can impact patients’ quality of life1–3C3 glomerulopathy (C3G) is a rare renal disease, affecting young patients with a poo…
The Committee voted 12 to 1 that the data presented support the use of Entresto in treatment of patients with heart failure with preserved ejection fraction (HFpEF)Potential Q1 2021 sNDA approval could make Entresto the first therapy indicated for use …
In Phase III KESTREL study, Beovu (brolucizumab 6 mg) achieved its primary endpoint of non-inferiority to aflibercept 2 mg in change in best-corrected visual acuity (BCVA) at year one (week 52)1In a secondary endpoint, more than half of Beovu patients …
The global pandemic has left virtually no part of the world untouched, and moved our industry to collaborate like never before, and leverage our expertise and resources to support the global response to the COVID-19 pandemic. The RUXCOVID clinical tria…
