Novartis hit with FDA letter detailing 'significant' Kymriah manufacturing shortfalls
Fierce Pharma
DECEMBER 7, 2023
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 l | In recent months, Novartis has faced scrutiny from the FDA over Kymriah production shortfalls, a newly posted letter shows. The company says it's working to address the situation.
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