Collaborative Review, Concurrent Approval.
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DOI: 10.1158/2159-8290.cd-nb2019-113
Abstract: In a regulatory first, the FDA has collaboratively reviewed a new cancer treatment with drug agencies in Canada and Australia, allowing for simultaneous approval of lenvatinib in combination with pembrolizumab for the treatment of recurrent… read more here.
Keywords: collaborative review; approval; concurrent approval; review concurrent ... See more keywords