Keeping Track: US FDA Approves Amgen’s Lumakras, Myovant’s Myfembree; New Claims For Biohaven’s Nurtec, BMS’ Zeposia
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
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FDA’s Rick Pazdur notes that while the agency recently allowed Amgen to conduct a key dose comparison study for its landmark KRAS inhibitor post-market it will be less willing to do this in the future, particularly in settings that are less refractory.
Myovant CEO David Marek talked to Scrip about why the companies believe patients and physicians will choose Myfembree over AbbVie's Oriahnn.
The company provided updates on the timing of some data from its extensive clinical program for its KRAS G12C inhibitor Lumakras, but not for certain high-profile combinations.