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Latest From Michael Cipriano
US FDA approved Yescarta without an advisory committee, as Novartis' first-in-class CAR-T cell therapy already set the stage for an agency review.
The final guidance adds some requested clarifications, but does not appear to address the US agency's tendency to designate products as drugs over devices, industry attorneys argue.
US FDA's tendency to designate products as drugs over devices may remain despite clarifications offered in final guidance.
Senators and witnesses rehashed years-old arguments and found little common ground on which elements of drug pricing to address.
The US National Institutes of Health will team up with 11 different drug-makers to explore new biomarkers with a vision of precision oncology medicine.
The latest US drug development news and highlights from our Performance Tracker.