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Press release / Oct 23, 2020

Novartis announces European Medicines Agency (EMA) has granted orphan drug designation for iptacopan (LNP023) in IgA nephropathy (IgAN)

Orphan drug designation is reserved for medicines treating rare, life-threatening or chronically debilitating diseases IgA nephropathy (IgAN), while rare, is the most common form of…
Press release / Mar 29, 2017

Novartis announces first CAR-T cell therapy BLA for pediatric and young adult patients with r/r B-cell ALL granted FDA Priority Review

Priority review for investigational CTL019 (tisagenlecleucel-T), a novel therapy that is manufactured for each individual patient using their own T cells Novartis made an early commitment to the…
Press release / Dec 22, 2017

Novartis' combination therapy Tafinlar® + Mekinist® granted FDA Priority Review for the adjuvant treatment of stage III BRAF V600 mutation-positive melanoma

Priority Review designation based on Phase III study showing 53% reduction in risk of recurrence or death with Tafinlar + Mekinist, as compared to placebo[1] Improvements observed in key…
Pulse Update / Sep 28, 2021

FDA grants Priority Review for investigational targeted radioligand therapy 177Lu-PSMA-617 for patients with metastatic castration-resistant prostate cancer (mCRPC)
Press release / Sep 06, 2019

Novartis investigational lung cancer therapy capmatinib (INC280) granted FDA Breakthrough Therapy Designation for patients with MET-mutated advanced non-small cell lung cancer

Currently, there are no targeted therapies approved to treat MET exon14 skipping-mutated non-small cell lung cancer (NSCLC), a particularly aggressive form of the diseaseBreakthrough Therapy…
Press release / Feb 11, 2020

Novartis announces MET inhibitor capmatinib (INC280), the first potential treatment for METex14 mutated advanced non-small cell lung cancer, granted priority FDA review

FDA Priority Review for capmatinib based on Phase II data in first-line and previously treated patients with MET exon 14 skipping (METex14) mutated advanced non-small cell lung cancer (NSCLC)1 …
Press release / Nov 02, 2018

Sandoz decides not to pursue US biosimilar rituximab; will focus on robust biosimilar portfolio for unmet access and sustainability needs

Decision follows FDA request for additional information to complement submission for biosimilar rituximab Sandoz stands behind safety, efficacy and quality of our biosimilar rituximab, which is…
Press release / Oct 21, 2020

Novartis receives US Food and Drug Administration (FDA) Orphan Drug Designation for branaplam (LMI070) in Huntington’s disease (HD)

Huntington’s disease is a rare, inherited neurodegenerative disease that leads to progressive disability and deathThere are no approved disease modifying therapies that delay disease onset or slow…
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…
Press release / Mar 03, 2020

International research partnership and EDCTP to invest €44m in next-generation antimalarials to combat drug-resistant malaria in Africa

EDCTP grants the PAMAfrica research consortium €21.9 million over a 5 year period; MMV, Novartis and other partners will provide an additional €22 million. The PAMAfrica consortium brings…