BioPharma Dive December 9, 2025
CAR-T cancer therapies now need to succeed in randomized, controlled trials to earn approvals. Elsewhere, a drug from Bristol Myers Squibb and BioNTech proved effective in breast cancer patients.
Today, a brief rundown of news from Bristol Myers Squibb, Novartis and Agios Pharmaceuticals, plus Food and Drug Administration officials who are proposing a new framework for testing CAR-T cell therapy for cancer.
Vinay Prasad and two other officials within the Food and Drug Administration office regulating many genetic medicines have outlined a stricter approval framework for the next CAR-T cell therapies developed for cancer. In an article published Monday in the Journal of the American Medical Association, the trio wrote that newer CAR-T treatments need to extend survival, or the...
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