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11 PDUFA dates on FDA’s agenda in September
Decisions due this month include BioLineRx’s Aphexda, Roche’s subcutaneous Tecentriq and GSK’s momelotinib
September 6, 2023 10:53 PM UTC
FDA has scheduled at least 11 target dates for drug reviews this month, nine for new applications and two for label extensions.
BioLineRx Ltd. (NASDAQ:BLRX; Tel Aviv:BLRX) has a PDUFA date on Saturday for what it is hoping will become its first marketed product, Aphexda motixafortide, a selective CXCR4 inhibitor under review for stem cell mobilization in autologous transplantation therapy for multiple myeloma...