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.

Bristol Myers Squibb thinks Turning Point’s ROS1/TRK inhibitor shows a best-in-class profile and potential to compete more successfully against Pfizer’s Xalkori than Roche’s Rozlytrek has.

Four Chinese biotech companies reach in- and out-licensing deals covering antibody drug conjugates, small molecules and vaccines as they continue to pursue and develop innovation.

The US FDA’s use of its advisory committees continues to shrink. In 2022, the expert panels appear primarily to serve as a last chance for sponsors to prevent (or overturn) an FDA rejection.