There’s A Therapeutic Curveball Heading For The FDA

Los Angeles, California-based Puma Biotechnology has shuffled a challenging new drug application (NDA) onto FDA’s desk.

Neratinib has polarized experts and investors over the last few weeks, with its data flaws and dubious benefit-to-risk ratio. The drug is currently under review for use in breast cancer patients who have had their tumors surgically removed.

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