The US FDA bracketed the Thanksgiving holiday with two new molecular entity approvals (NMEs) in oncology – Pfizer Inc.’s Daurismo (glasdegib) on Nov. 21 and Loxo Oncology Inc. and Bayer AG’s Vitrakvi (larotrectinib) on Nov. 26 – bringing the Center for Drug Evaluation and Research’s (CDER's) novel agent count for 2018 to a record-tying 53 approvals.
Vitrakvi, Daurismo Approvals Put US FDA On Brink Of Another Record
New oncologics bring CDER’s novel agent approvals count to 53 for the year.
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