Foundation Medicine, Inc.
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Latest From Foundation Medicine, Inc.
Three ANDA sponsors – HEC’s Sunshine Lake, Sigmapharm and Unichem – for generic versions of Eliquis had elected to take their Hatch-Waxman case to trial but were soundly beaten by originator’s Bristol-Myers Squibb and Pfizer. A launch in 2031 could now be their best, and only, option.
It has taken a while but European regulators have finally followed their US counterparts and approved Piqray, making it the first targeted medicine for HR+/HER2- advanced breast cancer with a PIK3CA mutation.
AACR 2020: Liquid Biopsy Company Guardant Health Presents Colorectal Cancer Data, Outlines Plans For Regulatory Approval
Guardant Health presented new clinical data at this week’s American Association for Cancer Research conference and outlined its growth plans as cancer testing volumes recover after the pandemic.
Keeping Track: Keytruda Claims First TMB-Based Cancer Indication; TG Therapeutics Submits First Umbralisib NDA
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.