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Press release / Mar 23, 2017

Alcon receives US FDA approval for new AcrySof® IQ ReSTOR® +2.5 Multifocal Toric IOL with ACTIVEFOCUS(TM) design for uncompromised distance vision and presbyopia correction

The unique optical design of the ACTIVEFOCUS(TM) toric IOL gives astigmatic cataract patients quality distance vision and an increased range of vision to potentially reduce dependence on glasses…
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…
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 / Jan 16, 2026

Novartis ianalumab receives FDA Breakthrough Therapy designation for Sjögren’s disease

Designation based on clinical evidence supporting potential of ianalumab in Sjögren’s disease, including phase III trials1Distinction expedites development and review of treatments for serious…
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 / 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 / Jan 26, 2018

Advanced Accelerator Applications Receives FDA Approval for Lutathera® for Treatment of Gastroenteropancreatic Neuroendocrine Tumors

Lutathera marks first FDA Approval for a Peptide Receptor Radionuclide Therapy (PRRT) Advanced Accelerator Applications is a newly established subsidiary of Novartis Lutathera…
Press release / Oct 31, 2017

Novartis submits application to FDA for KymriahTM (tisagenlecleucel) in adult patients with r/r DLBCL, seeking second indication for first-ever FDA approved CAR-T therapy

Submission based on updated analyses from global, multi-center Phase II JULIET study, which met primary endpoint, including 6-month data to be presented at ASH 2017 Kymriah has demonstrated…
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…
Press release / Jan 17, 2018

Novartis granted US FDA Priority Review for Kymriah(TM) (tisagenlecleucel), formerly CTL019, for adults with r/r DLBCL

Filing acceptance marks second Priority Review granted to Kymriah by the FDA for two distinct indications, underscoring the potential of first ever FDA-approved CAR-T therapy EMA granted…

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