FiercePharma

Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls

When it comes to manufacturing cell therapies, it's often said that the "process is the product." But churning out these complex, individualized drugs has routinely tripped up even the industry's ...
FiercePharma

Novartis' Kymriah bags FDA nod to face off against Gilead's Yescarta in follicular lymphoma

Novartis isn’t giving up on its CAR-T therapy Kymriah despite a recent high-profile trial flop. The drug has just scored an FDA nod that allows it to compete with Gilead Sciences’ rival, Yescarta, in ...
Nasdaq

FDA Oks Novartis Kymriah CAR-T Cell Therapy For Relapsed Or Refractory Follicular Lymphoma

(RTTNews) - Novartis said that the US Food and Drug Administration granted accelerated approval for Kymriah or tisagenlecleucel for the treatment of adult patients with relapsed or refractory or r/r ...
Nasdaq

Novartis five-year Kymriah® data show durable remission and long-term survival maintained in children and young adults with advanced B-cell ALL

In final ELIANA analysis, 55% of patients with relapsed or refractory (r/r) B-cell acute lymphoblastic leukemia (ALL) who were treated with CAR-T cell therapy Kymriah were still alive after five ...