The May 24 meeting of the Oncologic Drugs Advisory Committee (ODAC) was a happy day for two start-up sponsors, as the panel recommended approval for two very different applications that both benefitted from statistical re-analyses conducted by FDA during the review.
Puma Breaks A Long Losing Streak For Sponsors At ODAC
Puma is in select company after winning a strong vote from US FDA’s Oncologic Drugs Advisory Committee in favor of approval of its new cancer drug neratinib.
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