Keeping Track: Keytruda Claims First TMB-Based Cancer Indication; TG Therapeutics Submits First Umbralisib NDA
Executive Summary
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
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Finance Watch: Have Biopharma IPOs Hit Their Limit?
Public Company Edition: Three companies postponed or withdrew their offerings, but drug developers continue to pursue IPOs. Also, Biocon, BMS and Epizyme raised money through new debt, Five Prime capitalized on positive data and Synthetic Biologic engaged a strategic advisor.
Keeping Track: Kite’s Tecartus Is Third CAR-T With US FDA Approval; Submissions Round-Up
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker.
Merck's Keytruda Is First Checkpoint Inhibitor To Win US Approval Based On TMB Biomarker
Merck has secured FDA approval for Keytruda for use in tumors with high tumor mutational burden, something Bristol's Opdivo and AstraZeneca's Imfinzi were not able to do in lung cancer.