Lumakras withdrawal seems unlikely... for now
But a US adcom slams Amgen’s oversight of Codebreak-200, as the group’s KRAS rival Mirati surges on takeover talk.
Lumakras is the next test of FDA’s hardening stance
After Exkivity signals another accelerated approval slowdown the Amgen drug tomorrow faces an adcom over its own conditional approval.
Approval milestones – Hutchmed, SpringWorks, Crispr and Ionis eye firsts
A work-stretched US FDA has several key approval application still to review by the end of 2023.
12 years on, Jakafi faces serious JAK competition
Momelotinib gains full US approval in a broader setting than expected, validating GSK’s $1.9bn buyout of Sierra Oncology.
