HLB INC.'s Ripictu Receives Full FDA Approval for Cholangiocarcinoma Treatment

The U.S. Food and Drug Administration (FDA) has granted full approval to HLB INC.'s drug Ripictu (lirapugratinib) for the treatment of cholangiocarcinoma. This approval is notable as it was based on a single-arm Phase 1/2 clinical trial, rather than a randomized Phase 3 trial, due to challenges faced by earlier FGFR2 inhibitors in their confirmatory trials. The decision eases the burden of confirmatory clinical trials for Ripictu.