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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Novartis Scores Its First Tumor-Agnostic Label For Two Nearly Decade-Old Cancer Drugs
The FDA approved Tafinlar/Mekinist for BRAF V600E-mutated solid tumors, based in part on a Phase II basket trial studying more than two dozen drugs across dozens of cancers based on genetic testing.
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.