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Press release / Mar 30, 2021

Novartis receives EU approval for Kesimpta® (ofatumumab), the first and only self-administered, targeted B-cell therapy for adult patients with relapsing multiple sclerosis

There are more than 1 million people living with multiple sclerosis (MS) in Europe1, Kesimpta® (ofatumumab) addresses the current unmet need for a high-efficacy disease-modifying therapy (DMT) that…
Press release / Dec 16, 2020

Novartis investigational oral therapy iptacopan (LNP023) receives FDA Breakthrough Therapy Designation for PNH and Rare Pediatric Disease Designation for C3G

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…
Press release / Jan 21, 2015

Novartis announces FDA approval for first IL-17A antagonist Cosentyx(TM) (secukinumab) for moderate-to-severe plaque psoriasis patients

Offering a new treatment option for patients, Cosentyx is the first approved human monoclonal antibody (mAb) that selectively binds to interleukin IL-17A[1],[2] Phase III data demonstrated…
Press release / Mar 30, 2015

Novartis announces FDA approval for JadenuTM to simplify treatment administration for patients with chronic iron overload

Jadenu (deferasirox), a new formulation of Exjade (deferasirox), is the only once-daily oral tablet for iron chelation Jadenu, taken with or without food, simplifies daily treatment…
Ad hoc release / Sep 30, 2025

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 treatment1Well-controlled…
Press release / Sep 02, 2015

Novartis receives EU approval for new Revolade® use as first-in-class therapy for patients with severe aplastic anemia

Revolade is the first approved therapy in the EU for patients with severe aplastic anemia (SAA) who have not responded to other treatments Patients living with SAA, a rare blood disorder,…
Ad hoc release / Jun 01, 2018

Novartis receives positive CHMP opinion for Aimovig® (erenumab) for the prevention of migraine

If approved, Aimovig®(erenumab) is expected to be the first and only available therapy designed specifically for migraine prevention in the EU Positive opinion based on robust data package…
Press release / Nov 29, 2018

Novartis announces EU approval of Gilenya® for children and adolescents with MS, making it the first and only oral disease-modifying treatment for these patients in Europe

Approval based on landmark PARADIGMS study showing Gilenya (fingolimod) significantly reduced relapse rates by 82% vs interferon beta-1a; additionally, 85.7% of Gilenya patients were relapse-free…
Press release / May 27, 2021

Novartis and Molecular Partners announce start of EMPATHY clinical trial for ensovibep for the treatment of COVID-19

EMPATHY global multi-center Phase 2 - 3 study, recruiting patients with COVID-19 infection, aiming to prevent worsening symptoms and hospitalizationThe study plans to enroll 2100 patients, with 400…
Press release / Sep 04, 2015

Novartis receives EU approval for Farydak®, the first in its class of anticancer agents approved for patients with multiple myeloma

Farydak (panobinostat) combination is approved in the EU for patients with multiple myeloma who received >=2 prior regimens including bortezomib and IMiD[1] In clinical trials, Farydak…

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