FDA Granted Fast Track Designation for 225Ac-FL-020 for the Treatment of Metastatic CRPC

“The FDA Fast Track Designation for 225Ac-FL-020 underscores the critical need for innovative and effective treatments for mCRPC”, said Steffen Heeger, M.D., M.Sc., Chief Medical Officer of Full-Life. “This designation will enable us to collaborate more closely with the FDA throughout the development process, potentially accelerating the availability of 225Ac-FL-020 to patients.”

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