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Nanjing Leads Biolabs Co., Ltd. announced that the National Medical Products Administration and the U.S. Food and Drug Administration have approved its first-in-human Investigational New Drug applications for LBL-034, an anti-GPRC5D/CD3 bispecific antibody invented by Leads Biolabs with global intellectual property rights, for the treatment of relapsed/refractory multiple myeloma.

Transcenta Holding Limited announces that it has received approval from China Center for Drug Evaluation to initiate Phase II clinical trial of TST002.

Mesoblast Limited, global leader in allogeneic cellular medicines for inflammatory diseases, provided an activity report for the fourth quarter ended June 30, 2023.

Mithra announced the signing of a binding term sheet for a licensing agreement for the Canadian rights to Donesta®, an investigational medicine for the treatment of the symptoms of menopause.

Akeso Inc. announced that it is expected that the Company will record a profit of not less than RMB2.3 billion for the six months ended June 30, 2023.

GC Biopharma, a global biopharmaceutical company dedicated to specialty plasma-derived therapeutics, announced that the U.S. Food and Drug Administration has accepted the Company’s resubmission of the Biologics License Application for its GC5107B for patients with primary humoral immunodeficiency.

The FDA has three upcoming action dates in the next two weeks, including a highly anticipated decision regarding Biogen and Sage’s depression drug zuranolone.

With its hypoimmune technology, the company looks to reshape the future of cell and gene therapy.

Intercept’s failure to secure FDA approval for obeticholic acid (OCA) tablets in non-alcoholic steatohepatitis shines a light on safety challenges in the space, experts told BioSpace.

Aumentar el gasto energético diario de la actividad física puede proporcionar beneficios cardiometabólicos y disminuir el riesgo a largo plazo