The company said that the designation is supported by clinical data which demonstrates a 33% objective response rate for ...
Strong efficacy signals showing 33% ORR, 16.6-month PFS, and 27-month OS, improving on the SOC by 2-3X in a difficult-to-treat population Company to launch controlled study in second-line KRAS-mutant ...
The FDA Modernization Act of 1997 established the Fast Track designation to expedite developing and reviewing new drugs designed to fill unmet medical needs and treat serious conditions. The FDA Fast ...
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