Array BioPharma, Inc.
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Latest From Array BioPharma, Inc.
PD-1 Inhibitor Market Poised For A New Round Of Expansion: After GSK’s Jemperli Approval, US FDA Still Has Three Novel Candidates Under Review
Agenus’ recent submission of balstilimab joins novel checkpoint inhibitors from Incyte expecting FDA action this year; Junshi and Coherus’ ongoing rolling BLA for toripalimab is the first from the multiple PD-1/L1 inhibitor candidates developed in China that are vying to enter the US market.
Kyorin, Eisai build on earlier OAB deal to team on vibegron. Plus deals involving Piramal/Hemmo, ImmuneOncia/3D Medicines, Kyowa Kirin/Cerecor, Simcere/Kazia, Nippon Shinyaku/Menarini, Tarsus/LianBio
AstraZeneca's partner FibroGen stunned investors and regulators by announcing that previously disclosed cardiovascular safety data for CKD candidate roxadustat included changes made post hoc, rather than as pre-specified with the US FDA.
A new batch of marketing authorizations in Japan includes new therapies for high-need cancer indications and rare diseases, and the first nod worldwide for a novel lysosomal disorder treatment that can address serious CNS symptoms.
- In Vitro Diagnostics