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Story / Dec 04, 2023

Beacon of Hope lights the way for a more equitable future

Access to Healthcare

Sharing Key Insights and Lessons to Accelerate Progress.
Press release / Mar 25, 2022

Novartis receives positive CHMP opinion for Kymriah® CAR-T cell therapy for adult patients with relapsed or refractory follicular lymphoma in Europe

Positive opinion paves way for third indication in Europe for Kymriah, a potentially definitive single infusion CAR-T cell therapy treatment optionCHMP opinion based on Phase II global ELARA trial…
Press release / Nov 29, 2017

Novartis announces Phase III STRIVE data published in NEJM demonstrating significant and sustained efficacy of erenumab (AMG334) in migraine prevention

Patients with episodic migraine taking erenumab reported significant and meaningful benefits over six months, with reduced migraine days and acute medication use Fifty percent of patients…
Press release / Nov 27, 2018

Sandoz receives eighth European Commission approval for a biosimilar with Ziextenzo® (pegfilgrastim)

Biosimilar Ziextenzo® (pegfilgrastim), a long-acting version of supportive oncology medicine filgrastim, is now approved for use in all reference medicine indications [1] Ziextenzo is indicated…
Ad hoc release / Dec 18, 2020

Novartis receives complete response letter from U.S. FDA for inclisiran

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…
Press release / Nov 14, 2016

Novartis drug PKC412 (midostaurin) granted FDA Priority Review for newly-diagnosed FLT3-mutated AML and advanced systemic mastocytosis

Priority Review based on data from the largest clinical trials conducted to date in each indication[1],[2] Designation will shorten FDA expected review time to within six months[3]; EMA also…
Press release / Oct 23, 2015

Novartis receives positive CHMP opinion for the first IL-17A inhibitor Cosentyx(TM) to treat ankylosing spondylitis and psoriatic arthritis

Cosentyx (secukinumab) is recommended for approval in Europe for the treatment of ankylosing spondylitis (AS) and psoriatic arthritis (PsA) patients Cosentyx demonstrated rapid onset of…
Press release / Aug 30, 2017

Novartis receives first ever FDA approval for a CAR-T cell therapy, Kymriah(TM) (CTL019), for children and young adults with B-cell ALL that is refractory or has relapsed at least twice

First-in-class therapy showed an 83% (52/63) overall remission rate in this patient population with limited treatment options and historically poor outcomes [1],[2]. Novel approach to cancer…
Press release / May 01, 2018

Kymriah® (tisagenlecleucel), first-in-class CAR-T therapy from Novartis, receives second FDA approval to treat appropriate r/r patients with large B-cell lymphoma

Kymriah demonstrated an overall response rate of 50%, with median duration of response not yet reached at the time of data cut-off, indicating sustainability of response[1] Kymriah is the only…
Press release / Mar 04, 2019

Novartis data confirm rapid response and high efficacy of Cosentyx® in psoriasis patients for first time in China

Phase III study shows close to 9/10 patients who received Cosentyx® 300mg achieved clear or almost clear skin during the first 16 weeks of treatment (87%), with rapid onset of relief seen as early…

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