Brief: U.S. Food And Drug Administration Updates Prescription Drug User Fee Act Action Date For Lifileucel For The Treatment Of Advanced Melanoma

Iovance Biotherapeutics

14/09/2023 23:29

Sept 14 (Reuters) - Iovance Biotherapeutics Inc
 IOVA.O :
    * U.S. FOOD AND DRUG ADMINISTRATION UPDATES PRESCRIPTION
DRUG USER
FEE ACT (PDUFA) ACTION DATE FOR LIFILEUCEL FOR THE TREATMENT OF
ADVANCED MELANOMA
    * IOVANCE BIOTHERAPEUTICS - FDA EXTENDS PDUFA DATE TO FEB24,
2024
ON RESOURCE CONSTRAINTS AND AGREES TO WORK WITH IOVANCE TO
EXPEDITE REMAINING REVIEW
    * IOVANCE BIOTHERAPEUTICS INC - PRIORITY REVIEW CONTINUES
WITH
SUCCESSFUL FACILITY INSPECTIONS COMPLETED, NO MAJOR REVIEW
ISSUES
    * IOVANCE BIOTHERAPEUTICS - FDA IS ALSO ENGAGED & HAS
EXPRESSED NO
CONCERNS ON STATUS OF TILVANCE-301 CONFIRMATORY TRIAL IN
FRONTLINE ADVANCED MELANOMA

Source text for Eikon:  ID:nGNX3kdSj 
Further company coverage:  IOVA.O 

 (Reuters.Briefs@thomsonreuters.com)