Pedmark filed with EU and rolling submission completed with FDA for hearing loss.- Fennec Pharma
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GSK Australia is pleased to announce that the Therapeutic Goods Administration (TGA) has registered Zejula (niraparib) for the treatment of women with advanced high-grade ovarian, fallopian tube or primary peritoneal cancer following completion of first-line platinum-based chemotherapy.
Bristol-Myers Squibb K.K. announced that Japan’s Ministry of Health, Labour and Welfare has approved Abecma (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have either experienced disease progression on the last therapy or relapse after the last therapy.