U.S. FDA Fast Track Designation for vididencel in Acute Myeloid Leukemia (AML)
“As part of the preparations for continued clinical development of vididencel in AML, we continue to strengthen the program in all product-relevant aspects, including on the regulatory front,” commented Jeroen Rovers, MD PhD, Chief Medical Officer of Mendus. “The Fast Track Designation granted by the FDA adds substantial regulatory value to the vididencel program in the most important healthcare market worldwide. As Mendus advances vididencel into the next phase of clinical development in AML maintenance, the Fast Track Designation will allow the Company to engage more frequently with the FDA to optimally align its development plan.”
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