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Keeping Track: US FDA Approves Amgen’s Lumakras, Myovant’s Myfembree; New Claims For Biohaven’s Nurtec, BMS’ Zeposia

 
• By Bridget Silverman

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Keeping Track Feature image

The US Food and Drug Administration’s approval of Amgen, Inc.’s Lumakras (sotorasib) stood out even in a noteworthy week for the agency, which also saw approval of a novel imaging agent, a new women’s health product from Myovant Sciences Ltd. and Pfizer Inc., and new indications in migraine prophylaxis and ulcerative colitis.

Lumakras was approved only about five months after NDA submission, and less than three years after the first patient was dosed with sotorasib

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