Caliway Wins US FDA Clearance to Advance Phase 3b Trial of Fat-Reduction Drug

Caliway Biopharmaceuticals (TPE:6919) said the U.S. Food and Drug Administration has completed its 30-day review of an investigational new drug application for a Phase 3b study of CBL-514, allowing the trial to proceed. CBL-514 is an injectable treatment for reducing abdominal fat, according to a Friday Taiwan Exchange filing. The study, known as CBL-0303, will assess the long-term safety and durability of the drug's fat-reduction effect in participants who completed the company's Phase 3 trials. The company has not yet begun the new drug application process, the filing said.