Brief: Mendus Receives U.S. FDA Fast Track Designation For Vididencel In Acute Myeloid Leukemia

Mendus AB (publ)

08/09/2023 07:06

Sept 8 (Reuters) - Mendus AB (publ)  IMMUN.ST :
    * REG-MENDUS RECEIVES U.S. FDA FAST TRACK DESIGNATION FOR
VIDIDENCEL IN ACUTE MYELOID LEUKEMIA (AML)
    * MENDUS TODAY ANNOUNCED THAT IT HAS RECEIVED FAST TRACK
DESIGNATION FROM U.S. FOOD AND DRUG ADMINISTRATION (FDA) FOR
COMPANY'S LEAD PROGRAM, VIDIDENCEL, FOR TREATMENT OF ACUTE
MYELOID LEUKEMIA (AML) IN COMPLETE REMISSION WITH RESIDUAL
DISEASE
    * ADVANTAGES OF FAST TRACK DESIGNATION INCLUDE CLOSE AND
EARLY
INTERACTIONS WITH FDA TO SUPPORT ACCELERATED APPROVAL, AS WELL
AS POSSIBILITY OF A "ROLLING REVIEW" FOR A SUBSEQUENT MARKET
APPLICATION

Source text for Eikon:  ID:nGNE8vnShg 
Further company coverage:  IMMUN.ST 

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