Caliway Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat

Caliway Announces Successful EOP2 Meeting with the FDA for CBL-514 in Reduction of Abdominal Subcutaneous Fat

Caliway has completed the End-of-Phase 2 (EOP2) meeting with the U.S. FDA for CBL-514, the world's first investigational drug for large-area subcutaneous fat reduction developed under the 505(b)(1) regulatory pathway.The company has received the EOP2 meeting minutes, confirming the primary…

FDA Clears All-in-One Body Contouring System

The platform integrates fat removal, closed-loop contouring, tissue contraction, and electrosurgical capabilities. Apyx Medical Corporation, the manufacturer of a helium plasma and radiofrequency technology marketed and sold as Renuvion, has received 510(k) clearance from the US Food and Drug Administration for the AYON Body Contouring System. The company is preparing for a commercial launch of AYON with key surgeons in critical geographies star…

Caliway Biopharmaceuticals Announces Successful EOP2 Meeting With The FDA For CBL-514 In Reduction Of Abdominal Subcutaneous Fat - Medical Device News Magazine

Caliway has completed the End-of-Phase 2 (EOP2) meeting with the U.S. FDA for CBL-514, the world's first investigational drug for large-area subcutaneous fat reduction developed under the 505(b)(1) regulatory pathway.