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Experimental Drug Development Centre Granted U.S. FDA Fast Track Designation for Antibody-Drug Conjugate EBC-129 to Treat Pancreatic Ductal Adenocarcinoma

The Fast Track Designation facilitates the expedited development of EBC-129, enabling more frequent engagement with the FDA to discuss the clinical development plan. It also provides potential eligibility for Priority Review and Accelerated Approval, as well as rolling review of any future Biologic License Application (BLA). Read the article to find out more!

 

(Read more link: https://www.eddc.sg/experimental-drug-development-centre-granted-u-s-fda-fast-track-designation-for-antibody-drug-conjugate-ebc-129-to-treat-pancreatic-ductal-adenocarcinoma/)